Fluid Management Systems and Methods

ABSTRACT

Fluid management systems are disclosed that include software-controlled, electro-mechanical devices used in combination with single-use or multi-use tubing sets. Functions of the fluid management systems can include fluid pressurization, fluid warming, fluid deficit monitoring (including flow-based and weight-based), suction, fluid collection, and fluid evacuation (including indirect-to-drain and direct-to-drain options). The systems can be configured based on the surgical environment (e.g., operating room or physician office) as well as other user needs and/or preferences.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/091,670 filed on Nov. 6, 2020, pending issue, the entire disclosuresof which are fully incorporated herein by reference.

TECHNICAL FIELD

The present application is directed to fluid management systems and,more particularly, to fluid management systems and methods for surgicalprocedures.

BACKGROUND

Surgical fluid management systems are used in endoscopic procedures topressurize and deliver fluid to a surgical site for distending andcontinually flushing the surgical site to keep it free of blood anddebris for visualization purposes.

Fluid management systems may pressurize the fluid by manipulating theheight from which fluid supply bags are hung relative to the height ofthe surgical site, controlling the air pressure in pressure cuffs orpressure chambers surrounding the fluid supply bags, or by pumping thefluid, typically with a peristaltic pump. Gravity provides non-pulsatilefluid flow, but poor fluid pressure control. Similarly, pressure cuffsor chambers provide non-pulsatile fluid flow, but poor fluid pressurecontrol, unless the pressure in the cuffs or chambers is constantlyadjusted to account for the fluid volume exiting the fluid supply bags.Peristaltic pumps can provide good pressure control, but the pulsatilenature of the fluid flow may impair distention and visualization at thesurgical site.

Fluid management systems may warm the fluid in order to assist in themitigation or prevention of intraoperative hypothermia which can resultin adverse outcomes. Such systems, however, may lack precise fluidtemperature control, the ability to adequately warm fluid at the highfluid flow rates required for many procedures, and/or other capabilitiesrequired for certain surgical procedures (e.g., fluid deficit monitoringwhich is required for operative hysteroscopy). In facilities that lackfluid management systems with fluid warming capabilities, fluid bags maybe pre-warmed in warming cabinets prior to use during a surgicalprocedure. However, use of such warming cabinets can result indangerously hot fluid or, if the pre-warmed fluid is not used shortlyafter the pre-warming process has been completed, fluid that has cooledto room temperature and may contribute to intraoperative hypothermia.

Fluid management systems may include a deficit monitoring system forcalculating a deficit between an amount of a fluid supplied to asurgical site and an amount of fluid returned from a surgical site.Currently, fluid deficit monitoring is accomplished by subtracting thevolume of fluid supplied to the surgical site from the volume of fluidreturned from the surgical site into fluid collection canisters, bags,or vessels. The volume of fluid supplied is determined by monitoring theweight of the fluid source bags, counting the rotations of a peristalticpump, and/or manually recording the number and volume of fluid bagsutilized during the surgical procedure. The volume of fluid returned isdetermined by monitoring the weight of the canisters, bags, or vesselsand/or manually viewing and recording the fluid levels in suchcanisters, bags, or vessels using graduation marks. In order for thereturned fluid from the surgical site to move into the fluid collectioncanisters, the canisters are interconnected with tandem tubing and thenconnected to the surgical site and a suction source. If the fluidcollection canisters become full during the surgical procedure, theprocedure must be interrupted so that such canisters can be replaced.This process typically involves suspending suction, disconnecting thecanisters from the surgical site and suction source, disconnecting thetandem tubing, replacing the full canisters with new canisters,interconnecting the new canisters with tandem tubing, reconnecting thenew canisters to the surgical site and suction source, and resumingsuction. Due to the blood, tissue, and contaminated bodily fluidscollected, full fluid collection canisters require regulated “red bag”disposal unless treated with solidifiers that, in most states, allownon-regulated “white bag” disposal.

Fluid management systems may be connected to an internal or externalsuction source to pull fluid from a surgical site. As external suctionsources are often set to high suction levels in an operating roomenvironment, down-regulation may be necessary for proper operation ofcertain fluid outflow regulation, deficit monitoring, and/or collectionfunctions. Down-regulation of an external suction source to providedesired suction levels may be accomplished via a manually orelectronically controlled regulator. In order to isolate the regulatorfrom biohazardous fluid, fluid collection canisters, bags, or vesselsare typically placed between the regulator and the surgical site. Thesecanisters, bags, or vessels must be removed and replaced after theybecome full during a surgical procedure.

During endoscopic surgical procedures, a temporary increase in the fluidpressure and/or flow rate may be necessary to maintain or increasedistention and/or to maintain or increase fluid flow for proceduraland/or visualization purposes. To provide such a temporary increase, theuser may manually operate a syringe, bulb, or similar device that isconnected to the fluid inflow line of a surgical scope or instrument. Asthe duration of any increase in the fluid pressure and/or flow rateprovided by these manual methods is limited to the volume of fluidcontained in the syringe, bulb, or similar device, the necessaryincrease in the fluid pressure and/or flow rate may be interrupted whilethe syringe, bulb, or similar device is refilled with fluid. In otherinstances, the user may increase the fluid pressure by raising theheight of the fluid supply bag, manually squeezing the fluid supply bag,or manually pumping up the pressure in a pressure bag or cuffsurrounding the fluid supply bag. Alternatively, in some instances, theuser may increase the setpoint fluid pressure of a fluid managementsystem via a user interface such that the setpoint fluid pressure is setat a higher setpoint fluid pressure, and then the user decreases thesetpoint fluid pressure to the original setpoint fluid pressure or otherdesired setpoint fluid pressure when the increase in pressure or flow isno longer necessary.

SUMMARY

An exemplary embodiment of a pressure regulator includes a firstchamber, a second chamber, a third chamber, and a flexible membrane. Thefirst chamber has an inlet opening for fluidly connecting to an externalpressure source, the second chamber has an outlet opening for supplyinga regulated pressure to a regulated source, and the third chamber has apressure opening for connection to a pressure source. The flexiblemembrane fluidly isolates the third chamber from both of the first andsecond chambers, and the flexible membrane is movable by the pressuresource between a first position in which the flexible membrane fluidlyisolates the first chamber from the second chamber and a second positionin which the first and second chambers are fluidly connected.

An exemplary embodiment of a pressure regulator includes a firstchamber, a second chamber, a third chamber, a fourth chamber, and aflexible membrane. The first chamber has an inlet opening for fluidlyconnecting to an external pressure source, and the second chamber has anoutlet opening for supplying a regulated pressure to a regulated source.The third chamber has a pressure opening for connection to a pressuresource, and the fourth chamber has a sensing opening for connecting to apressure sensor that senses a pressure in the fourth chamber. Theflexible membrane fluidly isolates the third and fourth chambers fromboth of the first and second chambers. The flexible membrane is movableby a vacuum pressure applied to the first chamber such that the thirdand fourth chambers are fluidly connected, and the flexible membrane ismovable by a pressure applied by the pressure source such that the firstand second chambers are fluidly connected.

An exemplary embodiment of a fluid management system includes a pump anda disposable pressure regulator. The pump delivers fluid from a fluidsupply container to a surgical site. The disposable pressure regulatoris positioned between the surgical site and an external vacuum source.The disposable pressure regulator regulates a vacuum pressure providedby the external vacuum source to the surgical site, and the fluid fromthe surgical site passes through the pressure regulator prior to beingevacuated by the fluid management system.

An exemplary embodiment of a fluid management system includes a pump andan aspiration module assembly. The pump delivers fluid from a fluidsupply container to a surgical site. The aspiration module assemblyconnects to an external vacuum source and is positioned between thesurgical site and the vacuum source. The aspiration module assemblyincludes an aspiration module and a pressure regulator. The aspirationmodule has a pressure source and a pressure sensor. The pressureregulator removably connects to the aspiration module and includes afirst chamber, a second chamber, a third chamber, and a flexiblemembrane. The first chamber has an inlet opening for fluidly connectingto an external vacuum source, the second chamber has an outlet openingfor supplying a regulated pressure to a regulated source, and the thirdchamber has a one or more openings for connection to the pressure sourceand pressure sensor of the aspiration module. The flexible membranefluidly isolates the third chamber from both of the first and secondchambers, and the flexible membrane is movable by the pressure sourcebetween a first position in which the flexible membrane fluidly isolatesthe first chamber from the second chamber and a second position in whichthe first and second chambers are fluidly connected.

An exemplary embodiment of a fluid management system includes a pump andan aspiration module assembly. The pump delivers fluid from a fluidsupply container to a surgical site. The aspiration module assemblyconnects to an external vacuum source and is positioned between thesurgical site and the vacuum source. The aspiration module assemblyincludes an aspiration module and a pressure regulator. The aspirationmodule has a pressure source and a pressure sensor. The pressureregulator removably connects to the aspiration module and includes afirst chamber, a second chamber, a third chamber, a fourth chamber, anda flexible membrane. The first chamber has an inlet opening for fluidlyconnecting to an external vacuum source, and the second chamber has anoutlet opening for supplying a regulated pressure to a regulated source.The third chamber has a pressure opening for connection to the pressuresource of the aspiration module, and the fourth chamber has a sensingopening for connecting to the pressure sensor of the aspiration module.The flexible membrane fluidly isolates the third and fourth chambersfrom both of the first and second chambers. The flexible membrane ismovable by the external vacuum source such that the third and fourthchambers are fluidly connected, and the flexible membrane is movable bya pressure applied by the pressure source such that the first and secondchambers are fluidly connected.

An exemplary method of regulating a vacuum pressure supplied to asurgical site with a fluid management system includes configuring acontrol system of the fluid management system to provide a first vacuumpressure from the pressure source to a pressure regulator of the fluidmanagement system to move a flexible membrane disposed within thepressure regulator form a first position in which the flexible membranefluidly isolates an external vacuum source from a surgical site to asecond position in which the vacuum source and the surgical site arefluidly connected. Movement of the flexible membrane to the secondposition causes the vacuum pressure supplied to the surgical site topull fluid from the surgical site and through the disposable pressureregulator prior to being evacuated by the fluid management system.

An exemplary method of regulating a vacuum pressure supplied to asurgical site with a fluid management system includes configuring acontrol system of the fluid management system to provide a first vacuumpressure from the pressure source to a pressure regulator of the fluidmanagement system to move a flexible membrane disposed within thepressure regulator form a first position in which the flexible membranefluidly isolates an external vacuum source from a surgical site to asecond position in which the vacuum source and the surgical site arefluidly connected. Movement of the flexible membrane to the secondposition causes the vacuum pressure supplied to the surgical site topull fluid from the surgical site and into a fluid collection canisterthat is disposed between the surgical site and the pressure regulator.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary embodiment of a fluid management systemfor an operating room environment;

FIG. 2 illustrates an exemplary embodiment of a main unit of the fluidmanagement system of FIG. 1;

FIG. 3 illustrates an exemplary embodiment of a heater and fluidconditioner assembly of the main unit of FIG. 2;

FIG. 4 illustrates an exemplary cartridge assembly for insertion intothe heater and fluid conditioner assembly of FIG. 3;

FIG. 5 illustrates an exemplary fluid conditioner and fluid warmingcartridge of the cartridge assembly of FIG. 4 disconnected from eachother;

FIG. 6 illustrates an exemplary fluid path through the cartridgeassembly of FIG. 4;

FIG. 7 illustrates an exploded view of an IR lamp sub-assembly of theheater assembly of FIG. 3 with the cartridge assembly of FIG. 4;

FIG. 7A illustrates an exemplary embodiment of a threshold detector fora crossover circuit;

FIG. 7B illustrates an exemplary embodiment of a relay bank forinteracting with the crossover circuit of FIG. 7A, where the switches ofthe relay bank are in a first position;

FIG. 7C illustrates the relay bank of FIG. 7B, where the switches of therelay bank are in a second position;

FIG. 8 illustrates another exemplary embodiment of a fluid conditionerfor insertion into a fluid conditioning assembly of a fluid managementsystem;

FIG. 9 illustrates an exemplary alignment between the fluid conditionerof FIG. 5 and the fluid conditioning assembly of FIG. 3;

FIG. 10 illustrates a cross-sectional view of an exemplary embodiment ofa fluid conditioner for the cartridge assembly of FIG. 4;

FIG. 11 illustrates the fluid conditioner of FIG. 10 showing locationsof the fluid conditioner that are aligned with sensors of the fluidconditioning assembly of FIG. 3;

FIG. 12 illustrates a perspective view of the fluid conditioner of FIG.10;

FIG. 13 illustrates an exploded perspective view of the fluidconditioner of FIG. 10;

FIG. 14 illustrates a perspective view of an exemplary fluid warmingcartridge of the cartridge assembly of FIG. 4;

FIG. 15 illustrates an exploded perspective view of the fluid warmingcartridge of FIG. 14;

FIG. 16 illustrates a front view of the fluid warming cartridge of FIG.14 when fluid moving through it is at a low pressure;

FIG. 17 illustrates a front view of the fluid warming cartridge of FIG.14 when fluid moving through it is at a high pressure;

FIG. 18 illustrates a cross-sectional front view of the fluid warmingcartridge of FIG. 14 when fluid moving through it is at a high pressure;

FIG. 19 illustrates an exemplary embodiment of a main unit for the fluidmanagement system of FIG. 1, where the main unit includes an opening todraw air through the heater assembly of the main unit for coolingpurposes and another opening to exhaust the resulting warm air onto ornear one or more of the fluid supply bags or containers that are hangingfrom the fluid management system in order to pre-warm the fluid;

FIG. 20 illustrates a perspective view of an exemplary embodiment of adeficit module and a deficit cartridge for the fluid management systemof FIG. 1, where the deficit cartridge is inserted in the deficitmodule;

FIG. 21 illustrates a front view of the deficit module and deficitcartridge of FIG. 20;

FIG. 22 illustrates a right-side perspective view of the deficit moduleand deficit cartridge of FIG. 20, where the deficit cartridge is removedfrom the deficit module;

FIG. 23 illustrates a left side perspective view of the deficit moduleand the deficit cartridge of FIG. 20, where the deficit cartridge isremoved from the deficit module;

FIG. 24 illustrates a rear view of the deficit cartridge of FIG. 20;

FIG. 25 illustrates a side view of the deficit cartridge of FIG. 20;

FIG. 26 illustrates a side view of the deficit cartridge of FIG. 20 withvalve and port covers removed;

FIG. 27 illustrates the deficit cartridge of FIG. 20 aligned with amoveable manifold of the deficit module of FIG. 20, wherein the movablemanifold is in an open position relative to the deficit cartridge;

FIG. 28 illustrates the deficit cartridge of FIG. 20 aligned with amoveable manifold of the deficit module of FIG. 20, where the movablemanifold is in a closed position relative to the deficit cartridge suchthat connections are made between the deficit cartridge and the deficitmodule;

FIGS. 28A-28C illustrate an exemplary connection between a port of thedeficit cartridge of FIG. 20 and a connector of the movable manifold ofthe deficit module of FIG. 20;

FIG. 29 illustrates an exploded perspective view of the deficitcartridge of FIG. 20;

FIG. 30 illustrates a front view of the deficit cartridge of FIG. 20aligned with non-contact fluid presence sensors of the deficit module ofFIG. 20;

FIG. 31 illustrates a perspective view of the deficit cartridge of FIG.20 aligned with non-contact fluid presence sensors of the deficit moduleof FIG. 20;

FIG. 32 illustrates a side view of the deficit cartridge of FIG. 20;

FIG. 33 illustrates a side view of the deficit cartridge of FIG. 20 whenthe deficit monitoring feature of the fluid management system is in afill/measure cycle;

FIG. 34 illustrates a side view of the deficit cartridge of FIG. 20 whenthe deficit monitoring feature of the fluid management system is in afill/evacuation cycle;

FIG. 35 illustrates a cross-sectional top view of the deficit module ofFIG. 20;

FIG. 36 illustrates an exploded perspective view of the deficit moduleof FIG. 20;

FIG. 37 illustrates a perspective view of an exemplary deficit pumpmanifold assembly for the deficit module of FIG. 20;

FIG. 38 illustrates an exploded perspective view of an exemplary deficitcartridge receiving assembly of the deficit module of FIG. 20 forreceiving the deficit cartridge of FIG. 20;

FIG. 39 illustrates a perspective view of an exemplary manifoldconnection assembly of the deficit module of FIG. 20 and the deficitcartridge receiving assembly of FIG. 38;

FIG. 40 illustrates a left side perspective view of the deficit moduleof FIG. 20;

FIG. 41 illustrates a right-side perspective view of the deficit moduleof FIG. 20;

FIG. 42 illustrates a top view of the deficit module of FIG. 20;

FIG. 43 illustrates a cross-sectional view of the deficit module of FIG.20 taken along the line A-A shown in FIG. 42;

FIG. 44 illustrates a partial view of the deficit module shown in FIG.43 showing an exemplary manifold connection assembly for connecting thedeficit cartridge shown in FIG. 20, where the manifold connectionassembly is in a disengaged position relative to the deficit cartridge;

FIG. 45 illustrates the exemplary engagement mechanism shown in FIG. 44,where the manifold connection assembly is in the disengaged positionrelative to the deficit cartridge;

FIG. 46 illustrates a top view of the deficit module of FIG. 20;

FIG. 47 illustrates a cross-sectional view of the deficit module of FIG.20 taken along the line B-B shown in FIG. 46;

FIG. 48 illustrates a partial view of the deficit module shown in FIG.43 showing the exemplary manifold connection assembly of FIG. 44, wherethe manifold connection assembly is in an engaged and connected positionrelative to the deficit cartridge;

FIG. 49 illustrates the exemplary engagement mechanism shown in FIG. 44,where the manifold connection assembly is in the engaged and connectedposition relative to the deficit cartridge;

FIG. 50 illustrates another exemplary embodiment of the fluid managementsystem shown in FIG. 1;

FIG. 51 illustrates an exemplary embodiment of a fluid flow monitoringand evacuation module for the fluid management system of FIG. 50;

FIG. 52 illustrates a perspective view of an exemplary embodiment of anaspiration module and a pressure regulator for the fluid managementsystem of FIG. 1, where the pressure regulator is inserted in theaspiration module;

FIG. 53 illustrates a schematic view of an exemplary embodiment of thepressure regulator shown in FIG. 52;

FIG. 54 illustrates a schematic view of another exemplary embodiment ofthe pressure regulator shown in FIG. 52;

FIG. 55 illustrates a schematic view of the pressure regulator shown inFIG. 54 showing valves of the pressure regulator disposed in a series;

FIG. 56 illustrates a rear perspective of an exemplary embodiment of thepressure regulator shown in FIG. 54;

FIG. 57 illustrates a front perspective view of the pressure regulatorshown in FIG. 56;

FIG. 58 illustrates an exploded perspective view of the pressureregulator shown in FIG. 56;

FIG. 59 illustrates a top view of the pressure regulator shown in FIG.56;

FIG. 60 illustrates a rear view of the pressure regulator shown in FIG.56;

FIG. 61 illustrates a bottom view of the pressure regulator shown inFIG. 56;

FIG. 62 illustrates a side view of the pressure regulator shown in FIG.56;

FIG. 63 illustrates a cross-sectional view of the pressure regulatorshown in FIG. 56 taken along the lines C-C shown in FIG. 61;

FIG. 64 illustrates a perspective view of an exemplary connectionbetween the pressure regulator shown in FIG. 56 and an exemplaryreceiving mechanism for the aspiration module shown in FIG. 52;

FIG. 65 illustrates a perspective view of another exemplary embodimentof the pressure regulator shown in FIG. 54;

FIG. 66 illustrates an exploded perspective view of the pressureregulator shown in FIG. 65;

FIG. 67 illustrates a partial perspective view of the pressure regulatorshown in FIG. 65;

FIG. 68 illustrates a top view of the pressure regulator shown in FIG.65;

FIG. 69 illustrates a cross-sectional view of the pressure regulatorshown in FIG. 65 taken along the lines D-D shown in FIG. 68;

FIG. 70 illustrates a cross-sectional view of the pressure regulatorshown in FIG. 65 taken along the lines E-E shown in FIG. 68;

FIG. 71 illustrates a cross-sectional view of the pressure regulatorshown in FIG. 65 taken along the lines F-F shown in FIG. 68;

FIG. 72 illustrates a top cross-sectional view of an exemplaryconnection between the pressure regulator shown in FIG. 65 and anexemplary receiving mechanism for the aspiration module shown in FIG.52;

FIG. 73 illustrates a partial view of the exemplary connection betweenthe pressure regulator and receiving mechanism shown in FIG. 72 showinga connection between a port of the pressure regulator and a port of theaspiration module;

FIG. 74 illustrates a side cross-sectional view of an exemplaryembodiment of the aspiration module shown in FIG. 52;

FIG. 75 illustrates a rear perspective view of the aspiration moduleshown in FIG. 74;

FIG. 76 illustrates an exemplary prompt by the fluid management systemof FIG. 1 to a user via a user interface regarding the type of procedureto be performed;

FIG. 77 illustrates another exemplary prompt by the fluid managementsystem of FIG. 1 to a user via a user interface regarding the type ofprocedure to be performed;

FIG. 78 illustrates an exemplary prompt by the fluid management systemof FIG. 1 to a user via a user interface regarding the number of fluidtypes that will be used during a procedure;

FIG. 79 illustrates another exemplary prompt by the fluid managementsystem of FIG. 1 to a user via a user interface regarding the number offluid types that will be used during a procedure;

FIG. 80 illustrates another exemplary prompt by the fluid managementsystem of FIG. 1 to a user via a user interface regarding the number offluid types that will be used during a procedure;

FIG. 81 illustrates an exemplary embodiment of a procedure run screen ona user interface of a fluid management system when the fluid managementsystem is set to a pressure control mode;

FIG. 81A illustrates a means of calculating a compensation height forcalculating a pressure at a surgical scope or instrument;

FIG. 82 illustrates an exemplary embodiment of a procedure settingsscreen on a user interface of a fluid management system;

FIG. 83 illustrates an exemplary embodiment of a procedure run screen ona user interface of a fluid management system when the fluid managementsystem is set to a “Surgical Site” control mode;

FIG. 84 illustrates a flow chart for a fluid management system that isoperating in the surgical site control mode shown in FIG. 83;

FIG. 85 illustrates an exemplary embodiment of a procedure settingsscreen on a user interface of a fluid management system that includesoperating a bolus device;

FIG. 86 illustrates the procedure settings screen of FIG. 85;

FIG. 87 illustrates the procedure settings screen of FIG. 85;

FIG. 88 illustrates an exemplary embodiment of a procedure settingsscreen on a user interface of a fluid management system that includesoperating a printer of the fluid management system;

FIG. 89 illustrates an exemplary embodiment of a procedure settingsscreen on a user interface of a fluid management system that includesalert settings for notifying a user when a fluid supply container isbecoming depleted, where the system is in a timed setting;

FIG. 90 illustrates the procedure settings screen of FIG. 89, whereinthe system is in a percentage setting;

FIG. 91 illustrates the procedure settings screen of FIG. 89, whereinthe system is in a volume setting;

FIG. 92 illustrates an exemplary embodiment of a fluid management systemfor a physician's office environment, where fluid bags are attached tohanging members of the fluid management system; and

FIG. 93 illustrates the fluid management system of FIG. 92, where afluid supply bag and a fluid return canister are attached to hangingmembers of the fluid management system.

DETAILED DESCRIPTION

The Detailed Description describes exemplary embodiments of theinvention and is not intended to limit the scope of the claims in anyway. Indeed, the invention is broader than and unlimited by theexemplary embodiments, and the terms used in the claims have their fullordinary meaning, unless otherwise noted in the application. Featuresand components of one exemplary embodiment may be incorporated into theother exemplary embodiments. Inventions within the scope of thisapplication may include additional features, or may have less features,than those shown in the exemplary embodiments.

As described herein, when one or more components are described as beingconnected, joined, affixed, coupled, attached, or otherwiseinterconnected, such interconnection may be direct as between thecomponents or may be indirect such as through the use of one or moreintermediary components. Also as described herein, reference to a“member,” “component,” or “portion” shall not be limited to a singlestructural member, component, or element but can include an assembly ofcomponents, members, or elements. Also as described herein, the terms“substantially” and “about” are defined as at least close to (andincludes) a given value or state (preferably within 10% of, morepreferably within 1% of, and most preferably within 0.1% of).

In endoscopic surgical procedures, steady distention and clearvisibility are important to procedural efficacy and efficiency. Fluidmanagement systems are used to provide fluid to a surgical site suchthat a surgeon has the desired distention and visualization whileperforming a surgical procedure. Fluid management systems can also beused to remove fluid from the surgical site. The various embodiments offluid management systems described herein relate to modular systems thatinclude software-controlled, electro-mechanical devices or modules thatmay be used in combination with single or multiuse tubing sets. Themodular, surgical fluid management systems described herein are fullyconfigurable to meet user needs based on, for example, the types ofsurgical procedures being performed and the surgical environment.Exemplary functions of the fluid management systems described hereininclude fluid pressurization, fluid warming, fluid deficit monitoring,suction, suction regulation, fluid collection, and/or fluid evacuationinto a facility's waste disposal system. The fluid management systemscan be configured based on surgical discipline (e.g., gynecological,urological, and/or orthopedic procedures) and environment (e.g.,operating room or physician's office), as well as based on other needsand/or preferences of the user and/or facility. The fluid managementsystems may be capable of integrated suction and fluid collection and/ormay be compatible with third-party suction and fluid collection devices,as well as central suction systems of facilities where the fluidmanagement systems are used.

Referring to FIG. 1, an exemplary embodiment of a fluid managementsystem 100 for an operating room environment where gynecological,urological, and orthopedic procedures are performed is shown. The system100 includes an elevated structure 101, a main unit 102, a deficitmodule 104, a fluid collection module 106, and a fluid evacuation module108. The system 100 may also include an aspiration module 5201 (FIG.52), and/or a fluid flow and evacuation module 5101 (FIG. 51). In someembodiments, the elevated structure 101 includes wheels 103 such thatthe system 100 can be moved to a desired location within the operatingroom or to a storage area. The system 100 may be modular, such that thesystem 100 described above can be configured as desired by the user.

The main unit 102 may have a control system that includes one or moreprocessors (not shown) for controlling and/or communicating with thevarious modules and components of the system 100 or other facilityequipment. The various modules and components may also have one or moreprocessors (not shown) for performing designated functions and/orcommunicating with the control system of main unit 102 or other facilityequipment. The processor(s) may execute instructions (e.g., softwarecode) stored in memory (not shown) of the system 100 and/or executeinstructions inputted into the system by a user. In some embodiments,the control system may have “Bluetooth” capability for connecting toremotely located components or modules of the system 100 or otherfacility equipment and “Wi-Fi” capability for connecting to theinternet. The control system may include a touch-screen graphical userinterface 110 for receiving one or more inputs from a user anddisplaying information of the system 100 (e.g., information regardingfluid pressure, fluid volume, fluid temperature, fluid deficit, etc.).

Referring to FIGS. 1 through 3, the main unit 102 may also include apump 212 (e.g., a peristaltic pump) for fluid pressurization, a heaterassembly 314 for fluid warming, a fluid conditioning assembly 315 forsensing one or more fluid characteristics (e.g., fluid presence,temperature, etc.), hanging members 116 (e.g., hooks) for hanging fluidsupply and/or return containers (e.g., bags, canisters, vessels, etc.),and a printer 218 for printing out pertinent procedure information(e.g., information regarding procedure type, procedure start time,procedure end time, total fluid volume, average fluid pressure, totalfluid deficit, deficit by fluid type, average fluid temperature, etc.)during or after the surgical procedure. The processor of the controlsystem can be in communication with the pump 212, heater assembly 314,fluid conditioning assembly 315, pressure sensors 949 (FIG. 9), solenoidvalve 951 (FIG. 9), hanging members 116, printer 218, deficit module104, fluid collection module 106, fluid evacuation module 108,aspiration module 5201 (FIG. 52), fluid flow and evacuation module 5101(FIG. 51), and/or any other component of the system 100.

The pump 212 may be fluidly connected to the fluid container(s) that arehanging on the hanging members 116 such that the pump can pump fluidthrough a tubing set to a surgical scope or instrument (e.g.,hysteroscope, cystoscope, ureteroscope, nephroscope, etc.) at a surgicalsite. The tubing set may include a fluid conditioner (e.g., fluidconditioner 420 shown in FIG. 4 and described in the presentapplication) that works in combination with one or more non-contactsensors (e.g., non-contact sensors of the fluid conditioning assembly315 or any other non-contact sensors in the system 100) such that thesystem 100 can monitor one or more characteristics of the fluid that ismoving to the surgical site. The tubing set may also include a fluidwarming cartridge (e.g., fluid warming cartridge 422 shown in FIG. 4 anddescribed in the present application) that works in combination with theheater assembly 314 such that the system 100 can warm fluid that ismoving to the surgical site.

A suction source pulls fluid from the surgical site, through a tubingset, and either into a collection container of the collection module106, into a third-party fluid collection system, or into the wastedisposal system of the facility in which the system 100 is being used.In certain embodiments, the suction source is a vacuum pump that isintegral to main unit 102 or the fluid collection module 106. In someembodiments, fluid collection module also includes a pump and one ormore filters such that the fluid collection module can evacuate andfilter surgical smoke to eliminate potentially hazardous byproducts ofelectrosurgical procedures.

Referring to FIG. 1, the fluid collection module 106 may beindependently mobile and removably coupled to the elevated structure 101such that the module 106 can be removed from the elevated structure 101and transported to a waste disposal area or room for disposal of thecollected fluid. In some embodiments, the collection container of thecollection module 106 may include disposable liners that can easily bereplaced after the fluid has been evacuated from the suction andcollection module 106 and into the facility's waste disposal system. Insome embodiments, the suction source is external to the system 100 andpulls fluid to either the collection container of the collection module106, a third party-fluid collection system, or the waste disposal systemof the facility. In embodiments in which the fluid is pulled directlyinto the waste disposal system of the facility, the collection module106 may be bypassed or removed from the system 100 during use (e.g., asshown in FIG. 50). The fluid collection module 106 may include aprocessor that communicates with the main unit 102, the deficit module104, the aspiration module 5201 (FIG. 52), other components of thesystem 100, and/or other facility equipment. In some embodiments, thefluid collection module 106 may include a weight measuring mechanism(e.g., a scale) that allows the fluid management system 100 to determinea volume of fluid returning from the surgical site for fluid outflowand/or deficit monitoring purposes.

Prior to the fluid moving into the collection module 106, a third-partyfluid collection system, or a waste disposal system of the facility, thefluid may move through a single or multiuse deficit cartridge (e.g.,deficit cartridge 2010 shown in FIG. 25 and described in the presentapplication) such that the system 100 can calculate and monitor a fluiddeficit between fluid being provided to the surgical site and fluidbeing returned from the surgical site. The deficit cartridge may work incombination with the deficit module 104 (or the fluid flow andevacuation module 5101 shown in FIG. 51 and described in the presentapplication) and the main unit 102 to allow the system 100 to calculateand monitor the fluid deficit.

In certain embodiments, system 100 includes an aspiration module (e.g.,aspiration module 5201 shown in FIG. 52 and described in the presentapplication), and a single or multiuse pressure regulator (e.g., thepressure regulators 5205 shown in FIGS. 52-73 and described in thepresent application) that is fluidly connected to the tubing set and thesuction source. The pressure regulator and aspiration module may work incombination with each other and the main unit 102 to regulate a vacuumpressure provided to the surgical site by the suction source to pullfluid from the surgical site.

FIGS. 4 through 6 illustrate an exemplary embodiment of a cartridgeassembly 419 for a single or multiuse disposable tubing set of thesystem 100, where the cartridge assembly 419 includes a fluidconditioner 420 and a fluid warming cartridge 422. The fluid conditioner420 is configured to connect to the warming cartridge 422 to form thecartridge assembly 419 (as shown in FIG. 4). For example, referring toFIG. 5, the fluid conditioner 420 may have one or more connectionmembers 421 that are configured to connect to one or more connectionmembers 423 of the fluid warming cartridge 422. The connection members421, 423 of the fluid conditioner 420 and the fluid warming cartridge422 may be connected by, for example, a snap-fit connection, a frictionfit connection, etc. In other embodiments, the fluid conditioner 420 andthe fluid warming cartridge 422 may be connected by gluing,ultrasonically welding, or any other suitable means of joining the fluidconditioner and the fluid warming cartridge. In certain embodiments, thecartridge assembly 419 is a single, fully integrated component withcombined fluid conditioning and fluid warming functions. In theseembodiments, the single, fully integrated component of the cartridgeassembly 419 can be, for example, a single injection molded component.In certain embodiments, the cartridge assembly 419 is provided as afully assembled component of a single or multiuse tubing set. In someembodiments, the fluid conditioner 420 is provided as a fully assembledcomponent of a single or multiuse tubing set (e.g., including the fluidconditioner 420 and tube 841 assembly shown in FIG. 8), and the warmingcartridge 422 is provided as an accessory component that can be attachedto the fluid conditioner 420 if desired. In such embodiments, the usermay configure the tubing set for fluid warming by removing tube 841(FIG. 8) from the fluid conditioner 420 and connecting the warmingcartridge 422 to the fluid conditioner 420.

In certain embodiments, the main unit 102 can sense whether the fluidconditioner 420 has been inserted alone (e.g., without the warmingcartridge 422) into the system 100 or the cartridge assembly 419 (thatincludes the fluid conditioner 420 and warming cartridge 422) has beeninserted into the system. For example, the main unit 102 may include oneor more sensors (e.g., proximity sensors, mechanical sensors, opticalsensors, laser sensors, etc.) that can detect whether the fluidconditioner 420 alone or the cartridge assembly 419 was inserted intothe system 100. The control system of the system 100 can then enable thefluid warming function of the system 100 (e.g., the heater assembly 314shown in FIG. 3) when a warming cartridge 422 is inserted into thesystem 100 and disable the warming function when a warming cartridge 422is not inserted into the system 100.

Referring to FIG. 6, during use of the system 100, fluid may be pumpedthrough a first tube 624 of the tubing set and into an inlet port 625 ofthe fluid conditioner 420. The fluid then flows along a first flow path626 through an inlet chamber 1053 (FIG. 10) of the fluid conditioner,moves through an outlet port 527 (FIG. 5) of the fluid conditioner 420,and through an inlet opening 528 (FIG. 5) of the fluid warming cartridge422. The fluid then moves along a first side 1671 (FIGS. 16-18) of thewarming cartridge 422 along a fluid path 629, moves through a connectoror tube 530, and into a second side 1670 (FIGS. 16-18) of the fluidwarming cartridge 422 along a path 631. Subsequently, the fluid exits anoutlet opening 532 (FIG. 5) and moves through inlet port 533 (FIG. 5) ofan outlet chamber 1054 (FIG. 10) of the fluid conditioner 420, where thefluid moves along a path 636 such that the fluid exits outlet 634 of thefluid conditioner 422 and moves through a tube 635 of the disposabletubing set to a surgical instrument at a surgical site. The connector ortube 530 is shown as having a U-shape, but the connector or tube cantake any suitable form that causes the first and second sides of thewarming cartridge 422 to be fluidly connected. While the first andsecond sides of the fluid warming cartridge are shown being fluidlyconnected by the connector or tube 530, it should be understood that thefirst and second sides can be fluidly connected without the need for theconnector or tube 530. For example, the warming cartridge 422 can have achannel that fluidly connects the first and second sides.

In the illustrated embodiment. the fluid enters the fluid path 629through the inlet opening 528 (FIG. 5) of the warming cartridge 422 at alower position relative to the exit of the fluid path 629 at the inletof the connector or tube 530, and the fluid enters the fluid path 631 atthe exit of the connector or tube 530 at a lower position relative tothe outlet opening 532 (FIG. 5) of the warming cartridge 422. The enterlow, exit high configuration for each of the fluid paths 629, 631promotes a more uniform, controlled warming by reducing Eddy currentsand areas of stagnant flow. While the fluid is shown taking the fluidpaths 629, 631 through the warming cartridge 422, it should beunderstood that the fluid can take any suitable path through the warmingcartridge 422.

Inserting the cartridge assembly 419 into the main unit 102 of thesystem 100 aligns the fluid conditioner 420 with the fluid conditioningassembly 315 (FIG. 3) and the fluid warming cartridge 422 with theheater assembly 314 (FIG. 3). The fluid conditioner 420 may have ahandle 442 that allows a user to easily insert the cartridge assembly419 into the main unit 102.

Referring to FIG. 7, the heater assembly 314 (FIG. 3) may include an IRlamp assembly 737 used to warm the fluid moving along the fluid paths629, 631 (FIG. 6) of the warming cartridge 422. The IR lamp assembly 737may include a support structure 738, one or more elongated IR lamps withIR reflective coatings 739 disposed on each side of the warmingcartridge 422, and a parabolic reflector 740 disposed on each side ofthe warming cartridge 422 such that the parabolic reflector 740 focusesthe IR energy on the fluid paths. The heater assembly 314 may, however,utilize other types of IR lamps such as bulbs, rings, panels, circularmodules, or any other suitable forms that are capable of warming fluidmoving through the warming cartridge 422 or any other cartridge, tube,or vessel capable of exposing the fluid to IR lamps.

Referring to FIG. 8, in some embodiments, fluid warming may not bedesired or necessary during a procedure. In these embodiments wherefluid warming cartridge 422 is not necessary, a connector or tube 841 isused to connect the inlet chamber 1053 (FIG. 10) and the outlet chamber1054 (FIG. 10) of the fluid conditioner 420. While the inlet and outletchambers are shown being fluidly connected by the connector or tube 841,it should be understood that the inlet and outlet chambers can befluidly connected without the need for the connector or tube 841. Forexample, the fluid conditioner 420 can have a channel that fluidlyconnects the inlet and outlet chambers.

In an alternative embodiment, rather than utilizing the connector ortube 841, the fluid conditioner 420 may be included in a cartridgeassembly that has a pulse damping component (not shown) that is similarin construction to the warming cartridge 422 described below withreference to FIGS. 14-18, but the fluid damping component is not usedfor fluid warming. For example, the pulse damping component may includea rigid body (e.g., similar to rigid body 1472 shown in FIGS. 14-18) andflexible side sheets (e.g., similar to flexible side sheets 1473, 1474shown in FIGS. 14-18), where the rigid body and flexible side sheets atleast partially define a fluid path that connects the inlet chamber 1053(FIG. 10) of the fluid conditioner 420 to the outlet chamber 1054 (FIG.10) of the fluid conditioner 420. In alternative embodiments, the pulsedamping component may comprise a flexible vessel or channel without arigid body, in which the flexible vessel or channel defines a fluid paththat fluidly connects to the inlet chamber 1053 (FIG. 10) and the outletchamber 1054 (FIG. 10) of the fluid conditioner 420. In any of theembodiments described above, the flexible vessel or channel is capableof expanding and contracting to dampen the fluid pulsations. That is,the flexible vessel or flexible side sheets can expand and contract toreduce pulsations of the fluid as pressure of the fluid moving throughthe conduit fluctuates. This damping of the fluid pulsations facilitatessteady distention and good visualization during a surgical procedure.The fluid conditioner 420 and pulse damping component can be connectedby any suitable means, such as, for example, any means discussed in thepresent application regarding the connection of the fluid conditioner420 and the fluid warming cartridge 422. In certain embodiments, thefluid conditioner and pulse damping component can be included in anintegrated cartridge assembly where the fluid conditioner 420 and fluiddamping component are included in a single cartridge. In certainembodiments, the pulse damping component with a rigid body and flexibleside sheets or the flexible vessel or channel used for pulse damping maynot be connected to fluid conditioner 420, but instead be connected inthe tubing set between the outlet port 634 (FIG. 10) and the surgicalsite.

Referring to FIG. 9, the fluid conditioner 420 is configured to connector align with one or more non-contact sensors (e.g., sensors 943-950) ofthe fluid conditioning assembly 315 such that the sensors can sense oneor more characteristics of the fluid without contacting the fluid. Forexample, the fluid conditioning assembly 315 may include one or morefluid presence sensors (943, 947, 948, 950), one or more fluidtemperature sensors (944, 945, 946), and a port 1062 (FIG. 10) thatconnects to one or more pressure sensors 949 located in the main unit102. The port 1062 (FIG. 10) that connects to one or more pressuresensors 949 may also connect to a solenoid valve 951 for expellingexcess air that has accumulated in the fluid conditioner 420. Thepressure sensors 949 and the solenoid valve 951 may be connected to theport 1062 by one or more tubes or conduits and connection component 952.The control system of the fluid management system 100 may be configuredto at least partially control the pressurization of the fluid by pump212, the warming of fluid by the heater assembly 314, and the expellingof air from the fluid conditioner 420 based on the interface between thefluid conditioning assembly 315 (FIG. 3) and the fluid conditioner 420.

Referring to FIGS. 10 through 13, an exemplary embodiment of the fluidconditioner 420 may include a rigid body 1052 that defines a first orinlet chamber 1053 and a second or outlet chamber 1054. In someembodiments, fluid conditioner 420 may include a fully or partiallyenclosed middle chamber 1075 located between the inlet chamber 1053 andthe outlet chamber 1054 to provide a separation gap between walls of theinlet and outlet chambers. This separation gap created by the middlechamber 1075 prevents heat transfer between incoming and outgoing fluidthat would occur if the inlet chamber 1053 shared a common wall with theoutlet chamber 1054. The rigid body 1052 can be, for example, aninjection molded body. Referring to FIGS. 12 and 13, the fluidconditioner 420 may also include a film 1255 that is connected to therigid body 1052 to further define and enclose the chambers 1053, 1054 tocreate flow paths. The film 1255 can be connected to the rigid body 1052by gluing, laser welding, ultrasonic welding, or any other suitablemeans. The film 1255 is configured to allow one or more sensors of thesensing assembly 315 (FIG. 3) to sense one or more characteristics ofthe fluid moving through the inlet and outlet chambers 1053, 1054without contacting the fluid. The film 1255 can be, for example, aplastic film. In alternative embodiments, the fluid conditioner 420 doesnot include the film 1255, but rather the fluid conditioner 420 is arigid vessel that is configured to allow one or more sensors of thesensing assembly 315 (FIG. 3) to sense one or more characteristics ofthe fluid without contacting the fluid. In some of these embodiments, aportion of the rigid vessel that aligns with the sensors of the sensingassembly can have a reduced thickness relative to the remainder of thefluid vessel that allows the sensors to sense characteristics of thefluid. In the embodiments mentioned above, the inlet chamber 1053 mayhave an inlet port 625 and an outlet port 527, and the outlet chamber1054 may have an inlet port 533 and an outlet port 634. Outlet port 527and inlet port 533 can have O-rings (e.g., O-rings 1363 shown in FIG.13) for making water-tight connections. In certain embodiments, theinlet port 625 and outlet port 634 can have barbed and/or glued portionsfor connecting to fluid tubing.

Referring to FIGS. 9 through 11, the fluid inlet chamber 1053 is alignedwith a fluid presence sensor 943 that targets area 1156 and a fluidinlet temperature sensor 944 that targets area 1157. Operation of thepump 212 (FIG. 2) causes fluid to flow from a fluid supply bag orcontainer through inlet port 625 into the inlet chamber 1053. The inletchamber 1053 may have a protruding wall 1058 that causes a section ofthe chamber to become thin or shallow, which mitigates air bubblestagnation by causing laminar flow through this section. The fluidpresence sensor 943 verifies that fluid is present in the inlet chamber1053 and, therefore, can be used by the system 100 to monitorperformance and identify any problems. For example, if the pump isoperating, but fluid presence sensor 943 is not detecting fluid, thecontrol system may notify the user to check for a disconnected tubingline or possible occlusions of the fluid path between the fluidcontainers and the fluid conditioner 420, such as, for example, kinkedtubing or closed clamps.

The fluid temperature sensor 944 may have several functions. Forexample, in embodiments in which the heater assembly 314 is used to warmthe fluid to a desired temperature (e.g., a temperature inputted by theuser or a default system temperature), fluid temperature sensor 944allows the control system to monitor the temperature of the fluidentering the warming cartridge 422 such that the control system canadjust the amount of IR energy provided by the heater assembly 314 tocause the fluid entering the outlet chamber 1054 of the fluidconditioner 420 to be at the desired temperature. In addition, if theuser has hung pre-warmed fluid bags with fluid temperatures at high,potentially unsafe levels, the control system may disable the pump 212and/or the heater assembly 314, and then notify the user that suchoperations will remain disabled until the fluid temperature hassufficiently cooled or the fluid supply bags or containers have beenchanged. Alternatively, the control system may continue operation whileincreasing air flow through the heater assembly 314 to sufficiently coolthe fluid before it reaches the outlet chamber 1054 of the fluidconditioner 420. If such attempt fails, the fluid outlet temperaturesensor 945 that targets area 1159 and/or fluid high-limit or thermalcut-off temperature sensor (“TCO Sensor”) 946 that targets area 1160will cause the control system to disable the fluid pumping and warmingoperations until the temperature of the fluid has sufficiently cooled.Additionally, assuming an operating room environment where the user hasenabled the fluid warming function, the temperature sensor 944 can beused to notify the user if the temperature of the fluid entering thefluid conditioner 420 may be too cool to achieve the desired fluidtemperature. Finally, the control system can also determine if there isa problem with heater assembly 314. For example, if the temperaturesensor 944 detects that the temperature entering inlet chamber 1053 isacceptable, but sensor 945 detects that the temperature of the fluid didnot achieve the desired fluid temperature, the control system willnotify the user that there may be a problem with the heater assembly314.

Still referring to FIGS. 9 through 11, the outlet chamber 1054 of thefluid conditioner 420 may be designed to separate air bubbles from thefluid being delivered to the surgical site that may have been caused byfluid bag changes or the fluid warming process. For example, the fluidoutlet chamber 1054 may have a substantially vertical wall or baffle1061 (FIGS. 10-11) that causes air bubbles to separate from the fluidwhen the fluid engages the wall. As shown in the illustrated embodiment,the baffle 1061 may not be connected to a perimeter of the outletchamber 1054.

In certain embodiments, the outlet chamber 1054 is designed tofacilitate fluid pressure monitoring and control via pressure sensors949 located in the main unit 102. For example, insertion of the fluidconditioner 420 may cause a connection between the outlet chamber 1054of the fluid conditioner 420 with pressure sensors 949 located in mainunit 102 via pressure port 1062 and one or more tubes or conduits (notshown). As the pressure of the pocket of air trapped between the fluidin outlet chamber 1054 and the pressure sensors 949 is indicative of thefluid pressure, the control system monitors the fluid pressure beingread by the pressure sensors 949 in relation to the setpoint fluidpressure, and the control system adjusts the speed of the pump 212 toachieve and maintain the setpoint fluid pressure. To ensure pressuremonitoring accuracy and guard against over pressure conditions, thecontrol system constantly compares the readings of the pressure sensors949 to ensure they are the same excepting normal tolerances for suchsensors. Independent of software, the control system may employredundant hardware circuits that disable or reverse the pump 212 if thefluid pressure exceeds the maximum allowable pressure for the procedure.

To ensure that the pressure sensors 949 remain isolated from the fluid,the outlet chamber 1054 is designed not only to maintain a pocket of airbetween the pressure sensors 949 and the fluid, but also to include ahydrophobic filter 1065 that acts as a fluid barrier. Such hydrophobicfilter 1065 may also act as a bacterial barrier to preserve thesterility of the fluid. To protect the hydrophobic filter 1065 fromcoming into contact with fluid entering the outlet chamber 1054 underturbulent or high flow conditions, outlet chamber 1054 may include anarcing wall or barrier 1066 that, in combination with the baffle 1061,ensures that any fluid going over the top of the baffle 1061 is directedaway from the hydrophobic filter. The pressure port 1062 may alsoinclude an O-ring 1364 (FIG. 13) for making a fluid tight connection.

In addition to the presence sensor 943 for the inlet chamber 1053, theremay be at least three additional fluid presence sensors (947, 948, 950)that are aligned with the outlet chamber 1054. The fluid presence sensor947 (“fluid outlet sensor”) located at the outlet port 634 of the outletchamber 1054 targets area 1167 and is used to ensure proper flow offluid through the fluid conditioner 420. For example, if the controlsystem detects that the pump 212 is pumping fluid, but the fluid outletsensor 947 is not detecting fluid, the control system may disable thepump 212 and/or notify the user of a problem with the system 100. Inaddition, if the fluid warming function is present and enabled, thefluid outlet sensor 947 ensures that the fluid warming cartridge 422 isfull of fluid before the fluid warming function is commenced orcontinued.

The fluid presence sensor 948 located at the midpoint of the outletchamber 1054 targets area 1168 and is used to control the amount of airthat has accumulated in the outlet chamber 1054. During normaloperation, the fluid level in the outlet chamber 1054 should bemaintained proximate the midpoint of the outlet chamber. If fluid is notdetected by the fluid midpoint sensor 948, and the pressure sensors 949are reading a positive pressure, the control system opens the solenoidvalve 951 to expel excess air that has accumulated in the outlet chamber1054 until the fluid midpoint sensor 948 detects fluid (i.e., until thefluid level has increased to the midpoint of the outlet chamber 1054).To avoid materially impacting the pressure monitoring and controlfunction of the system 100, the solenoid valve 951 may have a smallorifice or restriction so that the excess air in the outlet chamber 1054bleeds off at a low, controlled rate. Alternatively, the system 100 canaverage the fluid pressure readings so that the effects of any minorpressure decreases associated with the air expelling function aremitigated, or the system 100 can ignore the fluid pressure readingswhile the solenoid valve 951 remains open.

The fluid presence sensor 950 located proximate the pressure port 1062of the outlet chamber 1054 targets area 1169 to ensure proper operationof the pressure sensing function of the system 100, which requires thata pocket of air be maintained between the fluid in the outlet chamber1054 and the pressure sensors 949 of the sensing assembly 315. Thepressure of this pocket of air, which is monitored by the pressuresensors 949, increases and decreases as a result of increases anddecreases in the fluid pressure. If the fluid level reaches thehydrophobic filter 1065 that protects the pressure port 1062, thecontrol system may lose the ability to accurately monitor the fluidpressure. Accordingly, if the fluid pressure port sensor 950 sensesfluid, the control system may disable pump 212.

Referring to FIGS. 6 and 14 through 18, if the system 100 includes amain unit 102 with fluid warming capability, for example when configuredfor an operating room environment, the fluid conditioner 420 willgenerally be connected to the fluid warming cartridge component 422.Joining the fluid conditioner 420 and fluid warming cartridge 422together form cartridge assembly 419 and causes fluid connections to bemade between the inlet chamber 1053 (FIG. 10) of the fluid conditioner420 and the first fluid path 629 (FIG. 6) on a first side 1671 (FIGS.16-18) of the warming cartridge 422. This connection also causes fluidconnections between the second fluid path 631 (FIG. 6) on the secondside 1670 (FIGS. 16-18) of the warming cartridge 422 and the outletchamber 1054 (FIG. 10) of the fluid conditioner 420.

The fluid warming cartridge 422 may include a rigid body 1472 (FIGS.14-18), a first thin flexible sheet 1473 (FIGS. 15-18), and a secondthin flexible sheet 1474 (FIGS. 15-18). Referring to FIGS. 16-18, thefirst flexible sheet 1474 is connected to a first side 1671 of the rigidbody 1472 to define the first fluid flow path 629, and the secondflexible sheet 1473 is connected to a second side 1670 of the rigid body1472 to define the second fluid flow path 631. In the illustratedembodiment, the first and second fluid flow paths 629, 631 are connectedby a connector or tube 530 (FIGS. 14-15). In other embodiments, thefirst and second flow paths may be connected by a channel that isintegral to the warming cartridge 422. The rigid body 1472 can be, forexample, an injection molded body. The flexible side sheets 1473, 1474can be made of, for example, plastic which is highly transmissive to IRto facilitate the fluid warming function. The rigid body 1472 and theflexible side sheets may be connected by gluing, laser welding,ultrasonic welding, or any other suitable means.

The flexible side sheets 1473, 1474 may be configured to expand andcontract to effectively dampen fluid pulsations generated by the pump212, which allows the fluid delivered to the surgical site to benon-pulsatile. That is, although the system 100 may utilize aperistaltic pump which generates a pulsatile fluid flow, the fluidwarming cartridge 422, which is downstream of the peristaltic pump, mayinclude thin, flexible side sheets 1473, 1474 to at least partiallydefine the fluid paths and expand and contract as the pressure of thefluid moving through the warming cartridge fluctuates to dampen thefluid pulsations. This damping of the fluid pulsations facilitatessteady distention and good visualization during a surgical procedure.

Referring to FIG. 6, in operation, fluid from the fluid supply bags orcontainers enters the fluid inlet chamber 1053 (FIG. 10) of the fluidconditioner 420 via port 625, enters the fluid warming cartridge 422,flows through the first elongated section of the fluid path 629 on afirst side 1671 (FIGS. 16-18) of fluid warming cartridge 422, exits thefirst elongated section of the fluid path and enters the secondelongated section of the fluid path 631 on a second side 1670 of thefluid warming cartridge via connector 530, exits the fluid warmingcartridge 422 and enters fluid outlet chamber 1054 of the fluidconditioner 420, and then exits the fluid outlet chamber 1054 fordelivery to the surgical site via port 634.

The system 100 can control fluid temperature by monitoring thedifference between the setpoint fluid temperature and the actual outletfluid temperature sensed by temperature sensor 945 (FIG. 9) to adjustpower to the IR lamp assemblies 737 (FIG. 7) in accordance withproportional integral control and scaling, which is based on the actualfluid flow rate and/or the difference between the actual fluidtemperature sensed by the temperature sensor 944 aligned with the inletchamber 1053 of the fluid conditioner 420 and the actual fluidtemperature sensed by the temperature sensor 945 aligned with the outletchamber 1054 of the fluid conditioner 420. Alternatively, other suitableopen-loop and closed-loop control systems can be employed, such as, forexample, proportional control, integral control,proportion-integral-derivative control, mathematical modelling,predictive function control, error squared control, and bang-bangcontrol.

In addition to the control scheme, the fluid warming efficiency can beenhanced by utilization of thin, flexible side sheets 1473, 1474 (FIG.15) of the fluid warming cartridge 422, which may be highly transmissiveto IR energy and an injection molded rigid body 1472 (e.g., a blackinjection molded body) that absorbs IR energy from the IR lampassemblies 737 (FIG. 7) and radiates the IR energy back to the fluid.Additionally, the fluid warming efficiency can be enhanced by theelongated sections of the fluid warming cartridge 422 that define fluidpaths 629, 631. The elongated sections of the fluid warming cartridge422 can facilitate uniform heat distribution by introducing fluid intoeach section at or below the centerline and exiting fluid from eachsection at the top of the opposite end such that the fluid moves from alower position to a higher position as it moves along each of the fluidpaths 629, 631.

Referring to FIG. 19, in certain embodiments, the fluid warmingefficiency of system 100 can also be enhanced by pre-warming of thefluid containers 1901. That is, air intake 1903 allows air to be drawnby fans 316 (FIG. 3) of heater assembly 314 (FIG. 3) into the main unit102 to cool the heater assembly 314 and the main unit 102 during thefluid warming process, and this air becomes heated as a result ofinteracting with the heater assembly 314. The heated air is thenexhausted by the main unit 102 through exhaust openings 1905 anddirected towards the fluid containers 1901 on each side of main unit 102such that the fluid within the fluid containers is pre-warmed prior tobeing pumped through the fluid conditioner 420 (FIG. 6) and fluidwarming cartridge 422 (FIG. 6).

To guard against overtemperature conditions, the system 100 has low andhigh limits that disable the IR lamps 739 (FIG. 7) if the fluidtemperature exceeds a low safety limit, and disables the IR lamps 739and the pump 212 if the fluid temperature exceeds a high safety limit.In some embodiments, independent of software, the system 100 employs ahardware circuit that includes the thermal cutoff sensor (“TCO”) 946(FIG. 9) to disable the IR lamps and the pump in an overtemperaturecondition exceeding the high limit. In some embodiments, the system 100employs a cooling fan to remove heat to help prevent and/or mitigateovertemperature conditions. The cooling fan may be electronicallycontrolled based on thermistor or other temperature sensor inputs and/orheating algorithm conditions that could lead to overtemperature (e.g. arapid decrease in flow rate where full heating was required at maximumflow rates).

Due in large part to the fluid warming function of the system 100, whichis intended to rapidly warm fluid up to the setpoint fluid temperatureand to maintain the setpoint fluid temperature at high flow rates, thesystem 100, for markets where the nominal supply voltage is 120V, mustbe connected to a dedicated 20-amp circuit. However, the system 100 canbe configured for connection to a standard 15-amp circuit by utilizinglower wattage lamps and/or current limiting power to the lamps. Incertain embodiments, fluid management system 100 is configured tooperate on nominal supply voltage of 120 v or 240 v without requiring achange in lamps. For example, the system 100 can include a crossovercircuit that includes a threshold detector 770 (FIG. 7A) and a relaybank 771 (FIGS. 7B-7C). Referring to FIG. 7, in certain embodiments, thelamp assembly 737 includes four lamps 739 (e.g., two lamps on each sideof the cartridge 419). FIG. 7B shows a circuit of a relay bank 771 fortwo lamps 739 of the lamp assembly 737 (e.g., two lamps 739 positionedon the same side of the cartridge 419) with relay contacts 775, 777 in afirst position in which the lamps 739 are placed into a parallelconfiguration. FIG. 7A shows a circuit for a threshold detector 770 thatcan cause the relay contacts 775, 777 (FIGS. 7B-7C) to move to a secondposition (as shown in FIG. 7C) in which the lamps 739 are placed into aseries configuration. While FIGS. 7B and 7C show a circuit for a relaybank 771 of two lamps 739 that are disposed on one side of the cartridge719 shown in FIG. 7, it should be understood that the circuit for theother two lamps 739 on the other side of the cartridge may be identicalto the circuit shown in FIGS. 7B and 7C.

Referring to FIG. 7A, the threshold detector 770 has an AC line input772 and an AC line input 774 that each connect to the input side ofbi-directional photocoupler 776, where the voltage being supplied to theheating assembly 314 is also applied to the inputs 772, 774. A firstZener diode 778 is positioned between the line input 772 and an input ofthe photocoupler 776, and a second Zener diode 780 is positioned betweenthe line input 774 and the input of the photocoupler 776. The Zenerdiodes 778, 780 prevent current flow from the inputs 772, 774 throughthe photocoupler 776 until the peak voltage applied to the inputs 772,774 is greater than or equal to a predetermined amount. The photocoupler776 includes a transistor output element 782 connected to voltage source784, where the transistor output element 782 is configured to operatebetween an “On” position and “Off” position with a line 786 thatgenerates a control signal used to energize relay coils 788 that operatethe relay bank 771. The transistor output element 782 remains off whencurrent is not moving through the input of the photocoupler 776, and thetransistor output element 782 turns on when the current flows throughZener diodes 778, 780 and enters the input of the photocoupler 776. Whenthe transistor output element 782 turns on, current from the voltagesource 784 energizes line 786 to generate the control signal to activatethe coils 788 a-d and move corresponding contacts (e.g., contacts 775,777) of the relay bank 771 from the first position (as shown in FIG. 7B)to the second position (as shown in FIG. 7C). In some embodiments, thecontrol signal is applied to a Schmitt trigger 790 and transistor array792 prior to energizing the coils 788 a-d. The Schmitt trigger 790ensures that the voltage on line 786 is stable and exceeds apredetermined limit prior to being connected to the transistor array.The transistor array 792 energizes coils 788a-d and moves the relaycontacts 775, 777 from the first position to the second position.

Referring to FIG. 7B, in the illustrated embodiment, the contacts 775,777 are in the first position when the lamps 739 are in a parallelconfiguration. When in the first position, the contacts 775, 777 areconnected at points 4 and 5 such that both lamps 739 are incommunication with the inlet 773 of the circuit. This allows half thecurrent moving through inlet 773 to move along a first path 779 into onelamp 739 and half the current to move through the second path 781(through the contact 775) and into the second lamp 739. In thisconfiguration, the same voltage applied to the inlet 773 is individuallyapplied across both of the lamps 739 such that each lamp 739 receivesthe voltage entering the circuit. For example, if 120 v is applied toinlet 773, the 120 v is connected to both the first path 779 and thesecond path 781 such that each lamp receives 120 v.

Referring to FIG. 7C, when the threshold detector 770 (FIG. 7A) causesthe contacts 775, 777 to move to the second position, an electricalconnection is made between points 3 and 5 such that the lamps 739 areconnected in a series configuration. In this configuration, all thecurrent applied to the inlet 773 moves along a single path 783 (becausethe disconnection between points 4 and 5 prevents the current frommoving directly through the contact 775 after entering the inlet 773)such that the current moves through one lamp 739, continues to movealong the path 783 such that the current moves through the contact 775at points 3 and 5, and the current then moves into the second lamp 739.Because both lamps 739 are disposed along a single path 783, the voltageapplied to the lamps 739 is split between the number of lamps disposedon the path 783. As the illustrated embodiment includes two lamps 739,each lamp 739 receives half of the voltage entering the inlet 773. Forexample, if 240 v is applied to inlet 773, all the current flows alongthe single path 783 such that the voltage drop across one lamp 739 is120 v and this dropped voltage is applied along the single path 783 suchthat the other lamp receives 120 v.

The fluid management system 100 may be configured to provide accurateand reliable flow-based deficit monitoring for surgical proceduresperformed in an operating room environment. For example, FIGS. 20through 49 illustrate an exemplary embodiment of a deficit module 104and a single or multiuse deficit cartridge 2010 for the fluid managementsystem shown in FIG. 1. The use of the deficit cartridge 2010 negatesthe need for canisters and avoids exposing the sensors and other durablecomponents of fluid management system 100 to the fluid returning fromthe surgical site. The deficit module 104 works in combination with thecontrol system of the main unit 102 and a single or multiuse tubing setthat includes the deficit cartridge 2010 to measure and record the fluidvolume being returned from the surgical site as it moves through deficitcartridge 2010. The fluid is pulled from the surgical site and both intoand out of the deficit cartridge 2010 by a suction source (e.g., avacuum pump integral or external to the system 100). In an alternativeembodiment, fluid may be pulled from the surgical site and pushed intothe deficit cartridge 2010 by a more positive pressure than presentinside deficit cartridge 2010 (e.g., a peristaltic pump integral orexternal to the system 100 inserted in-line between the surgical siteand the deficit cartridge 2010 and configured to create suction at thesurgical site and positive pressure at the inlet to the deficitcartridge 2010) and pulled from the deficit cartridge 2010 by a morenegative pressure than present inside deficit cartridge 2010 (e.g., avacuum pump integral to or external to the system 100 or a sufficientlypositive pressure inside the deficit cartridge 2010 due to the positivepressure created by the peristaltic pump to push the fluid out of thedeficit cartridge 2010 to ambient pressure).

Referring to FIGS. 20 through 23, the deficit cartridge 2010 is insertedinto the deficit module 104. The deficit cartridge 2010 may include afront section 2218 that aligns with an opening 2220 (FIGS. 22-23) of thedeficit module 104 and a raised portion 2222 (FIGS. 22-23) that allowsfor a user to easily grasp the deficit cartridge 2010 to remove thecartridge from the deficit module 104. The deficit cartridge 2010includes one or more inlet openings 2012, 2014 that are configured toconnect to one or more fluid return tubes of the tubing set such thatfluid can move from the surgical site and into the deficit cartridge2010. The deficit cartridge also includes at least one vacuum opening2016 that is configured to connect to an evacuation tube such that fluidmoves through the evacuation tube after moving through the deficitcartridge 2010. The evacuation tube is connected to the suction sourcesuch that a vacuum pressure is supplied to the deficit cartridge to pullfluid from the surgical site into and out of the deficit cartridge 2010.The fluid return and evacuation tubes may be manually connected to thedeficit cartridge 2010 after insertion of the deficit cartridge into thedeficit module 104.

The control system of the main unit 102 is configured to determine adeficit of fluid provided to the surgical site and returned from thesurgical site by comparing the volume of fluid moving through thedeficit cartridge 2010 to the volume of fluid being supplied to thesurgical site. The control system may calculate the volume of fluidbeing supplied to the surgical site by, for example, monitoring theweight of the fluid supply bags or containers (e.g., by using thehanging members 116 that are operatively connected to load cells),and/or counting the rotations of a peristaltic pump.

Referring to FIGS. 24 through 28, insertion of the deficit cartridge2010 into the deficit module 104 causes a manifold connection assembly2424 (FIGS. 27-28) to engage the deficit cartridge 2010 and connect, viaa pump manifold assembly (e.g., pump manifold assembly 3513 shown inFIG. 37), positive and negative pressure pumps (3515 and 3517,respectively, of FIGS. 35-36) and a pressure sensor (not shown) of thedeficit module 104 to pneumatically operated diaphragm regulators/valves(e.g., regulators/valves 2628, 2630, 2632, 2634 shown in FIG. 26) and apressure sensing area 2636 (FIG. 26) of the deficit cartridge 2010. Themanifold connection assembly 2424 has a plurality of connectors (e.g.,connectors 4510, 4511, 4512, 4513 shown in FIGS. 45 and 49) forreceiving corresponding ports 2540 for each of the regulators/valves andthe pressure sensing area of the deficit cartridge 2010. Referring toFIGS. 27-28 (and FIGS. 42-49), the connectors of the manifold connectionassembly 2424 can be configured to be moved between an engaged orconnected state and a disengaged or disconnected state relative to theports 2540 by a mechanical or electromechanical mechanism 2726 (e.g., amanual lever, a Pancake cylinder, or other type of pneumatic,mechanical, or electromechanical actuator). The ports 2540 of thedeficit cartridge 2010 may include an O-ring that allows for ahermetically sealed connection between the manifold connection assembly2424 and the deficit cartridge 2010. Insertion of the deficit cartridge2010 into the deficit module 104 also causes one or more non-contactfluid sensors 2742 (FIGS. 30-31) of the deficit module 104 to align withdesired locations of the deficit cartridge 2010.

The connectors (e.g., connectors 4510, 4511, 4512, 4513 shown in FIGS.45 and 49) of the manifold connection assembly 2424 may be configured toaccount for any manufacturing or assembly tolerances in the ports 2540of the deficit cartridge 2010. That is, the connectors may be configuredto move to ensure alignment with the corresponding ports 2540 of thedeficit cartridge 2010 to account for minor differences in the locationof the ports 2540 resulting from manufacturing and assembly of thedeficit cartridge 2010. For example, referring to FIGS. 28A-28C, incertain embodiments, a connector 4512 (also shown in FIGS. 45 and 49) ofthe manifold assembly 2424 may be a separate component that is connectedto the manifold assembly 2424 by an attachment element 2815 (e.g., anE-clip), and a receiving assembly 3511 (also shown in FIGS. 38-39) ofthe system 100 may include an opening 3828 (also shown in FIGS. 38-39)that is larger than the diameter of the connector 4512 for receiving theconnector 4512 such that the connector 4512 can move within the opening3828.

Referring to FIG. 28A, the manifold connection assembly 2424 is shown ina disengaged position with the port 2540 of the deficit cartridge 2010.Activation of the mechanism 2726 (FIG. 28) causes the manifoldconnection assembly 2424 to move in the direction M such that theconnector 4512 engages the port 2540 of the deficit cartridge 2010.

FIG. 28B shows the initial engagement between the connector 4512 and theport 2540, and FIG. 28C shows the completed engagement between theconnector 4512 and the port 2540. Referring to FIG. 28B, the port 2540of the deficit cartridge 2010 is not centered with the connector 4512,which causes the port 2540 to engage an edge of an inlet 2813 of theconnector 4512. The large opening 3828 of the receiving assembly 3511allows for the connector 4512 to move within the opening 3828 and alignwith the port 2540. That is, referring to FIG. 28C, continued movementof the manifold connection assembly 2424 in the direction M causes theport 2540 to align with and move into the connector 4512. In certainembodiments, the inlet 2813 of the connector 4512 is tapered tofacilitate movement of the port 2540 into the connector 4512. Theconnection described above between the connector 4512 and the port 2540allows for an easy and automatic connection between the deficitcartridge 2010 and the system 100 (e.g., via the deficit module 104).While FIGS. 28A-28C only show the connection between connector 4512 anda port 2540 of the deficit cartridge 2010, it should be understood thatthe other connectors (e.g., connectors 4510, 4511, 4512, 4513 shown inFIGS. 45 and 49) may be configured to connect to the ports 2540 of thedeficit cartridge 2010 in the same manner described in FIGS. 28A-28C.

Referring to FIGS. 29-34, the deficit cartridge 2010 may include asingle chamber 2944 with three sections 2946, 2948, 2950 that arefluidically connected. The three sections include a fill section 2946, ameasure section 2948, and an evacuation section 2950 that are fluidlyconnected at all times as the system 100 alternates between“Fill/Measure” and “Fill/Evacuation” Cycles, which allows the pressuregradient across the three sections to be minimized or substantiallyequal.

The fill section 2946 is fluidly connected to the inlet openings 2012,2014 such that fluid returning from a surgical site can move into thefill section 2946 through the inlet openings 2012, 2014. The evacuationsection 2950 is fluidly connected to the vacuum port 2016 such that asuction source can supply a vacuum pressure to the deficit cartridge2010 that causes fluid to move from the surgical site, into the deficitcartridge 2010 through the inlet openings 2012, 2014, and exit thedeficit cartridge 2010 through the vacuum port 2016. In otherembodiments, a pump in-line between the surgical site and port 2012and/or port 2014 (e.g., a peristaltic pump) may pull fluid from thesurgical site and push the fluid through the inlet openings 2012 and/or2014 and out of the deficit cartridge 2010 through the vacuum port 2016.Alternatively, a pump in-line between the surgical site and port 2012and/or port 2014 (e.g., a peristaltic pump) may pull fluid from thesurgical site and push the fluid through the inlet openings 2012 and/or2014 while a separate suction source supplies vacuum pressure to pullfluid out of the deficit cartridge 2010 through the vacuum port 2016.

One or more inlet valves 2628, 2630 may be positioned at the inletopenings 2012, 2014 and configured to close to prevent fluid fromentering chamber 2944 to avoid overfill conditions. In certainembodiments, the valves 2628, 2630 are pneumatically-operated diaphragmvalves that are connected to a pump assembly (e.g., an assemblyincluding positive pressure pump 3515 and negative pressure pump 3517shown in FIGS. 35-36) of the deficit module 104 such that the pumpassembly can move the valves 2628, 2630 between the open and closedpositions. In certain embodiments, a negative pressure pump of the pumpassembly opens the diaphragm valves and a positive pressure pump of thepump assembly assists closing of the diaphragm valves with positive backpressure.

The pneumatically-operated diaphragm valves 2628, 2630 may also work incombination with the pump assembly (e.g., an assembly including positivepressure pump 3515 and negative pressure pump 3517 shown in FIGS. 35-36)to act as a pressure regulator that regulates the vacuum pressure beingsupplied to the surgical site. That is, the control system of the fluidmanagement system 100 may be configured to adjust the amount of pressureapplied to the valves 2628, 2630 by the pump assembly, which adjusts thethreshold pressure required to displace flexible membrane 2956 and allowfluid to flow through 2628, 2630, and thereby allows the control systemto control the amount of vacuum pressure supplied to the surgical sitevia the suction source that is connected to the vacuum port 2016. Forexample, referring to FIG. 29, the valves 2628, 2630 may each include ahousing component 2958 that defines a chamber 2959, where the chamber2959 is connected to the pump assembly of the deficit cartridge. Aflexible membrane 2956 is disposed in the chamber 2959 and movablewithin the chamber 2959 by the pressure pumps. When the valves 2628,2630 are in the closed position, the membrane 2956 engages the chamber2944 of the deficit cartridge 2010 to fluidly isolate the fill section2946 from the inlet openings 2012, 2014. The pressure pumps areconfigured to move the flexible membrane 2956 within the chamber to openthe valves 2628, 2630, and the pump assembly can adjust the size of theopening by creating a desired pressure differential between the pressuresupplied by the pump assembly and the vacuum level within the chamber2944 of the deficit cartridge 2010. The membrane 2956 can be made of,for example, neoprene, silicone, natural rubber, nitrile, EPDM, or anyother suitable material. The valves 2628, 2630 may also have ahydrophobic filter 2960 to prevent fluid from traveling to the pumpassembly in case of a tear or other failure of the flexible membrane. Inother words, the valves 2628, 2630 work similar to the pressureregulator described with respect to FIGS. 52-73 of the presentapplication to regulate the vacuum pressure supplied to the surgicalsite.

In the illustrated embodiment, the fill section 2946 is positioned at atop portion of the chamber 2944, and the measure section 2948 ispositioned below the fill section 2946. A valve 2632 is positioned in anopening between the fill and measure sections 2946, 2948 and is movablebetween an open position and a closed position. When the valve 2632 isin the open position, the fill section 2946 and the measure section 2948are fluidly connected such that fluid in the fill section 2946 can moveinto the measure section 2948 via gravity. One or more sensors of thedeficit module 104 are used to measure the fluid within the measuresection 2948. In certain embodiments, the measure section includes amain area 3276 (FIG. 32) and a narrow area 3277 (FIG. 32) positionedabove the main area 3276, where the volume of fluid capable of beingdisposed in these areas 3276, 3777 are known by the system 100 such thatthe system can determine the volume of fluid moving through the measuresection 2948. The measuring of fluid within the measure section 2946will be described in more detail below. The evacuation section 2950 ispositioned below the measure section 2948, and a valve 2634 ispositioned in an opening between the measure and evacuation sections andis movable between an open position and a closed position. When thevalve 2634 is in the open position, the measure section 2948 and theevacuation section 2950 are fluidly connected such that fluid in themeasure section 2948 can move into the evacuation section 2950 viagravity. In the illustrated embodiment, the valves 2632, 2634 arepneumatically-operated diaphragm valves that are connected to a pumpassembly (e.g., an assembly including pumps 3515, 3517 shown in FIGS.35-36) of the deficit module 104 such that the pump assembly moves thevalves 2632, 2634 between the open and closed positions.

Referring to FIG. 32, the valves 2628, 2630, 2632, 2634 may include aflexible membrane (e.g., flexible membrane 2956 shown in FIG. 29) thatis movable between an engaged position and a disengaged position withopenings 3290 of the deficit cartridge 2010. That is, a portion of theopenings 3290 fluidly connect the inlets 2012, 2014 to the fill section2946, another portion of the openings 3290 fluidly connect the fillsection 2946 to the measure section 2948, and another portion of theopenings 3290 fluidly connect the measure section 2948 to the evacuationsection 2950. The flexible membranes of the valves 2628, 2630, 2632,2634 engage the openings 3290 to prevent movement of fluid between theinlets/sections, and disengage at least a portion of the openings 3290to allow movement of flow between the inlets/sections. The size andspacing of the openings 3290 may be configured to prevent extrusion ofthe flexible membranes through the openings 3290 when positive pressureis applied to the valves 2628, 2630, 2632, 2634. The size and spacing ofthe openings 3290 may vary based on the elasticity and/or thickness ofthe material of the flexible membrane. The number of openings 3290associated with each valve 2628, 2630, 2632, 2634 are configured toensure adequate flow of fluid through the deficit cartridge 2010. Incertain embodiments, the combined surface area of the openings on eachside of the valves 2628, 2630, 2632, 2634 is substantially equal to aninner cross-sectional area of tubing that is attached to the inlet ports2012, 2014 of the deficit cartridge 2010. Because gravity is thedominant force acting on the fluid to cause the fluid to move betweenthe sections 2946, 2948, 2950 of the chamber 2944, in some embodiments,the number of openings 3290 corresponding to the valves 2632, 2634 isconfigured to be large enough to allow sufficient flow through thevalves 2632, 2634 to achieve high flow rates. For example, the number ofopenings 3290 corresponding to each valve 2632, 2634 may be configuredto achieve a target flow rate of greater than or equal to 1200 ml/minthrough the chamber 2944 without stopping flow from the surgical site.In certain embodiments, because the measure section 2948 of the chamber2944 may be both filled and emptied while fluid continuously flows fromthe surgical site, the fluid flow rate through the valves 2632, 2634 maybe at least twice the target flow rate through the chamber 2944.

In the illustrated embodiment, the chamber 2944 includes a channel 2952that fluidly connects the fill section 2946 to the evacuation section2950 and a narrow portion 3277 that fluidly connects the fill section2946 to the measure section 2948. The channel 2952 and narrow portion3277 allow the fill, measure, and evacuation sections 2946, 2948, and2950 to be fluidly connected at all times, including when one or both ofthe valves 2632, 2634 are in the closed position. This fluid connectionbetween the fill, measure, and evacuation sections 2946, 2948, and 2950via the channel 2952 and narrow portion 3277 allows the pressuregradient across the three sections of the chamber 2944 to be minimizedor substantially equal such that the fluid is not caused to move withinthe chamber 2944 by a pressure source, but rather the fluid can movewithin the chamber 2944 due to gravity. In certain embodiments, thedeficit cartridge includes a wall 3252 that is positioned to preventfluid from entering the channel 2952 and bypassing the measure section2948. In an alternative embodiment, rather than the chamber 2944including the channel 2952, the deficit cartridge 2010 can include aconnector or tube (e.g., similar to tube 841 shown in FIG. 8 for thefluid conditioner 420) that fluidly connects the fill section 2946 tothe evacuation section 2950 such that the fill, measure, and evacuationsections 2946, 2948, and 2950 are fluidly connected at all times. Whilethe illustrated embodiment shows the three sections 2946, 2948, 2950being in a stacked configuration, in an alternative embodiment, thesethree sections can be in a side-by-side configuration, as long as thefluid can travel from the fill section 2946 to the measure section 2948to the evacuation section 2950 via gravity.

In various embodiments, the deficit cartridge 2010 includes a wastevacuum level sensing and regulation port 2636 for connecting to asolenoid valve which is open to ambient on one side and a pressuresensor of the deficit module 104. The control system of the fluidmanagement system 100 is capable of sensing the vacuum level of thechamber 2944 via the pressure sensor of the deficit module 104 andopening the solenoid valve to atmospheric pressure to down regulate thevacuum pressure being supplied to the deficit cartridge 2010 via thesuction source. Referring to FIG. 29, the port 2636 may include ahousing component 2973 that defines a chamber 2975, where the chamber2975 is connected to the solenoid valve and pressure sensor of thedeficit module 104. A flexible membrane 2977 is disposed in the chamber2975 and has an opening 2979 that enables pressure measurement of thepressure in chamber 2944 and exposes chamber 2944 to ambient when thesolenoid valve is open. The membrane 2977 can be made of, for example,neoprene, silicone, natural rubber, nitrile, EPDM, or any other suitablematerial. The port 2971 may also have a hydrophobic filter 2981.

Referring to FIGS. 30 through 32, the deficit cartridge 2010 is alignedwith one or more sensors 2742 (e.g., sensors 3062, 3064, 3066, 3068,3070 shown in FIGS. 30-31) of the deficit module 104 such that thecontrol system of the fluid management system 100 can use the sensors2742 to detect a volume of fluid moving through the chamber 2944 of thedeficit cartridge 2010 and/or detect any potential problems with fluidflow through the deficit cartridge (e.g., potential overflow of fluidwithin section 2946 of the chamber 2944). In the illustrated embodiment,the one or more sensors 2742 include a first fluid presence sensor 3062,a second fluid presence sensor 3064, a third fluid presence sensor 3066,a fourth fluid presence sensor 3068, and a fifth fluid presence sensor3070. Referring to FIGS. 32 through 34, in the illustrated embodiment,the first and second fluid presence sensors 3062, 3064 are aligned withfirst and second areas 3271, 3272, respectively, within the fill section2946. These fluid presence sensors 3062, 3064 are used by the controlsystem to close one or both of the inlet valves 2628, 2630 if the fluidwithin the fill section 2946 reaches the first and second areas 3271,3272. The third fluid presence sensor 3066 is aligned with a third area3273 in the measure section 2948 of the chamber 2944 and is used by thecontrol system to switch from Fill/Measure cycle to the Fill/Evacuationcycle and determine a volume of fluid within the measure section 2948prior to switch to the Fill/Evacuation cycle. The fourth fluid presencesensor 3068 is aligned with a fourth area 3274 within the measuresection 2948 and is used by the system to switch from theFill/Evacuation cycle to the Fill/Measure cycle. The fifth fluidpresence sensor 3070 is aligned with a fifth area 3275 within themeasure section 2948 and is used by the system to provide more accuratereal-time fluid volume measurement in measure section 2948 and todetermine a volume of fluid in the measure section 2948 after theprocedure is completed or the type of fluid being monitored forrecording a fluid deficit is changed to provide a more accurate fluiddeficit calculation for the fluid. While the illustrated embodimentshows the deficit module 104 having five fluid presence sensors fordetecting fluid flow conditions and volume within the chamber 2944 ofthe deficit cartridge, it should be understood that any other suitablenumber of fluid presence sensors can be used by the deficit module todetect fluid flow conditions and volume. The target areas 3271-3275 mayinclude walls partially surrounding them to mitigate the effects offluid turbulence on the accuracy of the sensor readings and any flexingof the film 2980.

Referring to FIG. 29, in the illustrated embodiment, the deficitcartridge 2010 includes a rigid body 2978 and a film 2980. The rigidbody 2978 partially defines the various sections 2946, 2948, 2950 andthe channel 2952 and narrow portion 3277 of the chamber 2944, and thefilm 2980 is attached to the rigid body 2978 to enclose the chamber2944. The rigid body 2978 can be, for example, an injection molded bodyor any other suitably rigid body. The film 2980 is configured to allowthe one or more sensors of the deficit module 104 to detectcharacteristics of the fluid through the film without contacting thefluid. The film 2980 can be, for example, a plastic film. The film 2980can be attached to the rigid body 2978 with mechanical fasteners or bygluing, laser welding, vibration welding, ultrasonic welding, or anyother suitable means. In alternative embodiments, the deficit cartridge2010 does not include film 2980, but rather is made of an injectionmolded vessel that is capable of having the one or more sensors of thedeficit module 104 detect characteristics of the fluid through thevessel without contacting the fluid. In other alternative embodiments,vessel may be cast or machined out of a material that is capable ofbeing cleaned and reused.

FIGS. 33 and 34 illustrate the Fill/Measure cycle and theFill/Evacuation cycle for the deficit cartridge 2010. Referring to FIG.33, during the Fill/Measure cycle, fluid returning from the surgicalsite is pulled from the surgical site into the fill section 2946 of thedeficit cartridge 2010 through inlet ports 2012, 2014 via a vacuumpressure from a suction source that is attached to vacuum port 2016. Thediaphragm operated valve 2632 is in the open position, which allowsfluid to travel from the fill section 2946 to the measure section 2948via gravity. The diaphragm operated valve 2634 is in the closedposition, which prevents fluid from the measure section 2948 from movinginto the evacuation section 2950. The Fill/Measure cycle continues untilthe fluid level in the measure section 2948 has reached a predeterminedlevel as sensed by the fluid presence sensor 3066 (FIGS. 30-31) of thedeficit module 104 that targets area 3273. In the illustratedembodiment, the targeted area 3273 is disposed in a narrow portion 3277(FIG. 32) of the measure section 2948 that extends above from the mainportion 3276 (FIG. 32) of the measure section 2948. The volume of fluidin the narrow portion 3277 is small compared to the volume of fluid inthe main portion 3276 of the measure section 2948 and, therefore,variables including fluid flow rates and turbulence (which can affectthe accuracy of the sensed fluid level) do not materially affect theoverall accuracy of the measuring function. In certain embodiments, aratio of the volume of the main portion 3276 to a volume of the narrowportion can be greater than or equal to 5 to 1, such as greater than orequal to 20 to 1, such as greater than or equal to 50 to 1, such asgreater than or equal to 75 to 1, such as greater than or equal to 90 to1, such as greater than or equal to 100 to 1. In an exemplaryembodiment, the ratio of the volume of the main portion 3276 to thevolume of the narrow portion can be about 100 to 1. The volume of fluidwithin the main portion 3276 and narrow portion 3277 of the measuresection 2948 are known by the system 100, which allows the system torecord the volume of fluid within the measure section for each time theFill/Measure cycle occurs. The system 100 records the volume and thentransitions to the Fill/Evacuation cycle.

Referring to FIG. 34, during the Fill/Evacuation cycle, the diaphragmoperated valve 2632 is moved to the closed position, which preventsfluid from the fill section 2946 from moving into the measure section2948. The diaphragm operated valve 2634 is moved to the open position,which allows the fluid that was measured in the measure section 2948during the Fill/Measure cycle to move into the evacuation section 2950via gravity. The fluid entering the evacuation section 2950 is thenevacuated through the vacuum port 2016, via the attached suction source,and the fluid is moved to the facility's waste disposal system viaindirect-to-drain or direct-to-drain methods. To evacuate fluid from theevacuation section, the evacuation cycle relies upon a vacuum pressuredifferential between the vacuum pressure provided by the suction sourceand the down-regulated vacuum pressure inside of the chamber 2944 (asregulated via the pressure regulation and sensing port 2636). When thefluid presence sensor 3068 (FIGS. 30-31) that targets area 3274 detectsno remaining fluid in the measure section 2948, the system 100transitions back to the Fill/Measure cycle. The alternation between theFill/Measure cycle and the Fill/Evacuation cycle continues until theprocedure is completed, and the control system determines the fluiddeficit of the fluid based at least partially on the various volumemeasurement recordings taken during the various Fill/Measure cycles.

The movement of fluid from the fill section 2946 to the measure section2948 and the evacuation section 2950 is accomplished with gravity, asopposed to external suction or pressure sources. In these embodiments,the valves may be sized to minimize resistance and thereby facilitatehigh flow rates with relatively low forces. The pneumatically-actuateddiaphragm valves 2628, 2630 accomplish the allowance or stoppage of flowinto the deficit cartridge 2010, and the pneumatically-actuateddiaphragm valves 2632, 2634 accomplish the allowance and stoppage offlow between the sections, 2946, 2948, 2950, by setting the pneumaticcontrol pressure by the pressure pumps 3515, 3517 (FIGS. 35-36) of thedeficit module 104 to a more positive gauge pressure than thecombination of 1) the highest pressure expected on either wetted side ofthe valve, and 2) any additional pressure required to account for theadditional force from the spring coefficient of the valve membrane.

To guard against overflow conditions, the deficit module 104 may have afluid presence sensor 3064 (FIGS. 30-31) that targets area 3272, and thecontrol system may be configured to close the fluid return valve 2628(e.g., the valve connected to the underbody drape and/or floor suctionat the surgical site) if the fluid presence sensor 3064 detects fluid atthe target area 3272. This ensures that the fill section 2946 does notoverfill and flow into the measure section 2948 through narrow portion3277 or the evacuation section 2950 through the channel 2952, andensures that the remaining capacity of the fill section remainsavailable to receive fluid returning from the surgical instrument at thesurgical site so as not to interrupt the surgical procedure. The deficitmodule may also have a fluid presence sensor 3062 (FIGS. 30-31) thattargets area 3271, and the control system may be configured to close thefluid return valve 2630 (e.g., the valve connected to a surgicalinstrument at the surgical site) if the presence sensor 3062 detectsfluid at the target area 3271. In an alternative embodiment, the valve2628 can be connected to the surgical instrument at the surgical site,and the valve 2630 can be connected to the underbody drape and/or floorsuction at the surgical site.

To provide end of procedure fluid deficit accuracy (assuming the end ofthe surgical procedure does not coincide with the end of a Fill/Measureor Fill/Evacuation cycle), the deficit module 104 may include one ormore midpoint fluid presence sensors (e.g., sensor 3070) that target oneor more areas (e.g., area 3275) to provide more accurate real-timemeasurement of the fluid in measure section 2948 and to measure thefluid in the measure section 2948 at the end of a surgical procedure orafter the type of fluid being used during the surgical procedure hasbeen changed.

FIGS. 35 through 48 illustrate an exemplary embodiment of a deficitmodule 104 that can be used with the fluid management system 100 shownin FIG. 1 and the deficit cartridge 2010 shown in FIGS. 20-34. Referringto FIG. 35, the deficit module 104 may include a deficit cartridgereceiving assembly 3511 for receiving the deficit cartridge 2010, one ormore sensors 2742 for sensing characteristics of fluid moving throughthe deficit cartridge without contacting the fluid, a pump assembly3514, a pump manifold assembly 3513, a manifold connection assembly 2424for connecting the deficit cartridge 2010 to the pump assembly 3514 anda solenoid and pressure sensor (via the pump manifold assembly 3513), apneumatic mechanism 2726 that moves the manifold connection assemblybetween an engaged position (e.g., as shown in FIGS. 47-49) and adisengaged position (e.g., as shown in FIGS. 43-45) with the deficitcartridge 2010, and a printed circuit board (PCB) 3519.

Referring to FIGS. 38 and 39, the deficit cartridge receiving assembly3511 includes a base 3821 having a slot or opening 3820 for receivingthe deficit cartridge 2010 (FIGS. 30-34). The receiving assembly 3511also includes one or more walls or components 3822-3826 thatsubstantially separate the deficit cartridge 2010 from the remainder ofthe components within the interior of the deficit module 104 when thedeficit cartridge 2010 is disposed within the receiving assembly 3511.The walls or components 3822-3826 and base 3821 can be connected by oneor more fasteners 3827 to create the receiving assembly 3511. A firstwall 3822 of the receiving assembly 3511 can be configured to hold theone or more sensors 2742 for sensing characteristics of fluid movingthrough the deficit cartridge 2010. In the illustrated embodiments, theone or more sensors 2742 are capacitive sensors that detect fluidpresence. However, other fluid level or presence sensing technologiescould be utilized including infrared sensors, laser sensors, opticalsensors, electro-mechanical sensors (e.g. float with mechanical toggleswitch actuation, piezo-electric pressure sensors, etc.), inductivesensors, ultrasonic sensors, or any other suitable sensors.

A second wall 3823 of the receiving assembly 3511 can include aplurality of openings 3828 for receiving connectors (e.g., connectors4510-4513 shown in FIGS. 45 and 49) of the manifold connection assembly2424 such that the pump assembly 3514 can be operatively connected tothe diaphragm valves and pressure port of the deficit cartridge 2010, asdiscussed in more detail below with references to FIGS. 42-49. Referringto FIG. 39, the manifold connection assembly 2424 can be connected to orpositioned adjacent to the wall 3823 of the receiving assembly 3511, andthe pneumatic mechanism 2726 can be connected to the manifold assembly2424 by one or more fasteners and to the deficit module 104 by aconnection element or plate 3930.

Referring to FIGS. 35 and 36, in the illustrated embodiment, the pumpassembly 3514 includes a positive pressure pump 3515 and a negativepressure pump 3517, where the pump assembly 3514 is connected to thepneumatic mechanism 2726 and the connectors of the manifold connectionassembly 2424 via the pump manifold assembly 3513. The positive pressurepump 3515 provides pressure to the pneumatic cylinder 2726 to move themanifold connection assembly 2424 between the engaged position (e.g., asshown in FIGS. 47-49) and the disengaged position (e.g., as shown inFIGS. 43-45) with the deficit cartridge 2010. The positive pressure pump3515 also expedites closing or augments closing force of the diaphragmvalves of the deficit cartridge 2010. The negative pressure pump 3517provides a vacuum pressure to the diaphragm valves of the deficitcartridge 2010 to move the diaphragm valves to the open position.

Referring to FIG. 37, in the illustrated embodiment, the pump manifoldassembly 3513 includes a plurality of accumulators 3732 and solenoidvalves 3734 for regulating pressure provided by the pumps 3515, 3517 andthe opening and closing of the diaphragm valves of the deficit cartridge2010. In certain embodiments, the accumulators 3732 vary the positiveand negative pressures to: (1) allow for the use of smaller pressurepumps that can deliver the necessary flow rates; and (2) aid pressureregulation by reducing the impact of introducing air via a “bang-bang”control scheme (i.e., an open valve, close valve control scheme). In theillustrated embodiment, the pump manifold assembly 3513 includes fiveaccumulators 3732 (e.g., holes that extend through the assembly 3515)that are capped off at the top and bottom by caps 3735). The solenoidvalves 3734 of the pump manifold assembly 3513 may connect to theconnectors of the manifold connection assembly 2424 via tubing.

Referring to FIGS. 42-49, the pneumatic mechanism 2726 is shown movingthe manifold connection assembly 2424 between a disengaged position(FIGS. 43-45) with the deficit cartridge 2010 and an engaged position(FIGS. 47-49) with the deficit cartridge 2010. Referring to FIGS. 43-45,when in the disengaged position, the ports 2540 for the diaphragm valvesand pressure port of the deficit cartridge 2010 are not engaged by theconnectors 4510-4513. Referring to FIGS. 47-49, the manifold connectionassembly 2424 is moved to the engaged position in the direction D (FIG.49) by the pneumatic mechanism 2726 such that the connectors 4510-4513engage a corresponding port 2540 of the deficit cartridge 2010. When theconnectors 4510-4513 are engaging the ports 2540 of the deficitcartridge 2010, the pump assembly 3514 is operatively connected to thedeficit cartridge 2010 such that the pump assembly 3514 can move thediaphragm valves of the deficit cartridge between the open and closedpositions and the vacuum pressure supplied to the deficit cartridge 2010can be sensed by a pressure sensor in the deficit module and downregulated by opening a solenoid to atmosphere.

Referring to FIGS. 35-49, in certain embodiments, insertion of thedeficit cartridge 2010 into the receiving assembly 3511 of the deficitmodule 104 causes all of the internal connections between the deficitcartridge 2010 and the various components of the deficit module 104. Forexample, insertion of the deficit cartridge 2010 into the receivingassembly 3511 causes the pneumatic mechanism 2726 to move the manifoldconnection assembly to the engaged position with the deficit cartridge(e.g., as shown in FIGS. 47-49) and operatively connect the pumpassembly 3514 to the deficit cartridge. Insertion of the deficitcartridge 2010 into the receiving assembly 3511 also causes the one ormore non-contact sensors 2742 to be aligned with the chamber 2944 (FIG.29) of the deficit cartridge 2010. These automatic connections betweenthe deficit cartridge 2010 and the deficit module are advantageousbecause it limits the amount of connections a user has to make withrespect to the deficit cartridge 2010. That is, after inserting thedeficit cartridge 2010 into the deficit module 104, a user only needs toconnect fluid return line(s) to inlet openings 2012, 2014 (FIG. 20) ofthe deficit cartridge 2010 and an evacuation line to a vacuum opening2016 (FIG. 20) of the deficit cartridge.

Referring to FIG. 50, in certain embodiments, the system 100 may be usedfor gynecological, urological, and orthopedic procedures that areperformed in operating rooms that are equipped with third party suctionand fluid collection devices. In these embodiments, the system 100 canbe configured to include a main unit 102 (e.g., any main unit 102described in the present application) and a deficit module 104 (anydeficit module 104 described in the present application), but notinclude the fluid suction and collection module 106. In this embodiment,a tubing set that includes deficit cartridge 2010 (FIGS. 20-34) can beused in combination with the main unit 102 and the deficit module 104 todetermine a fluid deficit of a fluid during a surgical procedure.

Referring to FIG. 51, in some situations, gynecological, urological, andorthopedic procedures are performed in operating rooms in which thefacility prefers or requires “direct-to-drain” disposal of fluidsreturning from the surgical site. In these situations, the facilityoften prefers or requires the volume of the fluid being returned fromthe surgical site be recorded. In some embodiments, the system 100 canbe configured to include a fluid flow monitoring and evacuation module5101 that includes features of the deficit module 104. The fluid flowmonitoring and evacuation module 5101 can work in combination with thecentral suction system of the facility, main unit 102, and a tubing setthat includes a deficit cartridge 2010 (FIGS. 20-34) or other similarcartridge to determine a fluid volume returning from the surgical siteand entering a waste disposal system of the facility, as well as a fluiddeficit for the surgical procedure. The fluid flow monitoring andevacuation module 5101 may communicate with the main unit 102 viaBluetooth or other wired or wireless means to measure, record, anddisplay the return fluid volume and/or fluid deficit for the surgicalprocedure.

While the fluid flow monitoring and evacuation module 5101 is describedas working in combination with the main unit 102 of the fluid managementsystem 100, it should be understood that the fluid flow monitoring andevacuation module 5101 may also function as a stand-alone fluid flowmonitoring and evacuation module capable of communicating with otherequipment of the facility via Bluetooth or other wired or wirelessmeans. After recording the fluid volume, module 5101 can then dispose ofthe fluid directly into a waste disposal system of the facility. Incertain embodiments, the fluid flow monitoring and evacuation module5101 can be a wall mounted unit or a cart mounted unit. In someembodiments, the fluid flow monitoring and evacuation module 5101 caninclude an integrated suction source to work in combination with, or inplace of, the central suction system of the facility. As use of thedeficit cartridge 2010 or other similar cartridge isolates the fluidreturning from the surgical site from the components (e.g., sensors,pumps, etc.) of the fluid flow monitoring and evacuation module 5101,circulation of cleaning solution through the fluid flow monitoring andevacuation module after each procedure is not necessary, which enhancesprocedure efficiency.

The flow-based deficit monitoring feature of the system 100 (e.g., thecombination of the deficit module 104 and the deficit cartridge 2010, orthe fluid flow monitoring and evacuation module 5101) enables accurateand reliable fluid deficit monitoring that is cost-effective due to thesingle-use nature of the deficit cartridge 2010 and the elimination ofcanisters. This feature also enhances procedure efficiency asinterruptions associated with setting up, connecting, changing, anddiscarding of the canisters will also be eliminated, as well as cleaningthe deficit module and/or monitoring and evacuation module after eachprocedure. In alternative embodiments, the deficit cartridge 2010 may beconfigured for multi-procedure use.

In certain situations, the fluid management system 100 may be connectedto an external pressure source (e.g., a suction source) that is used topull fluid from the surgical site. As external suction sources areusually set to high vacuum levels in an operating room environment,down-regulation of the vacuum pressure provided by the external suctionsource may be necessary for proper operation of certain fluid outflowregulation, deficit monitoring, and/or collection functions.Down-regulation of a vacuum pressure provided by an external suctionsource can be accomplished via a manually or electronically-controlledregulator (“Regulator”) provided it is isolated from the biohazardousfluid returning from the surgical site because replacing or cleaning theRegulator after every surgical procedure would be prohibitivelyexpensive and/or unduly burdensome. However, isolating the Regulator byplacing fluid collection canisters between it and the surgical site isnot desirable due to the costs of the canisters, the complexity ofsetting them up, the need to change them during the procedure when theybecome full, and the need to dispose of them at the end of theprocedure.

Referring to FIG. 52, to overcome the problems associated with the useof a Regulator, the system 100 may utilize a single-use or multi-usepressure regulator 5205 that is cost-effective to manufacture anddisposable. The pressure regulator 5205 does not need to be isolatedfrom the biohazardous fluids returning from the surgical site because ofits disposability. The pressure regulator 5205 can be used incombination with a pressure source (e.g., an air pump) and one or morepressure sensors of the fluid management system 100 to sense andregulate the vacuum pressure provided by an external suction source tocontrol the rate of fluid outflow from a surgical site and, thereby,assist in efforts to provide good distention and visualization. Thepressure pump and pressure sensors may be included in an aspirationmodule 5201 that is configured to be operatively connected to thecontrol system of the fluid management system 100, or the pressure pumpand pressure sensors may be integral to the main unit 102 of the fluidmanagement system 100. In embodiments that include the use of theaspiration module 5201, inserting the pressure regulator 5205 into theaspiration module 5201 causes fluidic connections between the pressureregulator 5205 and the pressure sensing and gas bleed mechanisms andintegrated pressure pump of the aspiration module 5201. After insertingthe pressure regulator 5205 into the aspiration module 5201, the usercan manually connect an external suction source and the fluid returnlines from the surgical site to connection ports 5202 (e.g., openings5315, 5317 shown in FIG. 53 and openings 5415, 5417 shown in FIGS.54-55) of the pressure regulator 5205.

Referring to FIG. 53, a first exemplary embodiment of the pressureregulator 5205 includes three chambers 5307, 5309, 5311 and a flexiblemembrane 5313. The first chamber 5307 includes an opening or port 5315for fluidly connecting to the external suction source. The secondchamber 5309 has an opening or port 5317 for fluidly connecting to thesurgical site (via one or more fluid lines or tubes). The third chamber5311 includes one or more ports for connecting to a pressure source(e.g., pressure source 7449 of aspiration module 5201 shown in FIG. 74)and a pressure sensor (e.g., pressure sensors 7451 of aspiration module5201 shown in FIGS. 74-75). In the illustrated embodiment, the thirdchamber 5311 has a first opening 5319 for connecting to the pressuresensor and a second opening 5321 for connecting to the pressure source.

The flexible membrane 5313 is positioned to fluidly isolate (i.e., seal)the third chamber 5311 from both of the first chamber 5307 and thesecond chamber 5309, which allows the pressure source and pressuresensor of the fluid management system 100 (which are connected to theopenings 5319, 5321 of the third chamber 5311) to be fluidly isolatedfrom biohazardous fluid returning from the surgical site and movingthrough the first and second chambers 5307, 5309. In some embodiments, ahydrophobic filter (not shown) is disposed between the flexible membrane5313 and the openings 5319, 5321 to provide further protection inpreventing fluid from contacting the pressure source and pressure sensorof the fluid management system 100. For example, the hydrophobic filtercan prevent fluid from contacting the pressure source and regulator ifthe flexible membrane 5313 tears or ruptures.

The first chamber 5307 is adjacent to the second chamber 5309 andseparated from the second chamber 5309 by a substantially verticalextended member or wall 5323 and a substantially horizontal extendedmember or wall 5361. The wall 5361 includes openings 5363 that fluidlyconnect the first chamber 5307 to the second chamber 5309. The pressuresource of the fluid management system 100 is configured to move theflexible membrane 5313 between an engaged position with the wall 5361and one or more disengaged positions with the wall 5361, where the firstand second chambers 5307, 5309 are fluidly isolated from each other whenthe flexible membrane is in the engaged position, and where the firstand second chambers 5307, 5309 are fluidly connected to each other (viaopenings 5363) when the flexible membrane 5313 is in one of thedisengaged positions. The size and spacing between of the openings 5363prevent the membrane 5313 from rupturing due to over-extrusion throughthe openings when positive pressure is applied to stop flow across thevalve. The size and spacing of the openings 5363 may vary based upon theelasticity and thickness of the material for flexible membrane 5313. Thenumber of openings 5363 can ensure adequate flow, and, in someembodiments, the total combined surface area of the openings on eitherside of each valve may be roughly equivalent to, or greater than, theinner cross-sectional area of the tubing expected to be attached to theport 5315.

The fluid management system 100 is configured to provide pressure to thethird chamber 5311 through opening 5319, and the system 100 isconfigured to sense and regulate the pressure within the third chamber5311 by sensing pressure via the pressure sensor and opening 5321 andmodulating the pressure provided by the pressure source to achieve thedesired pressure setpoint (e.g., by modulating the air pump speed ofpressure source 7449 of aspiration module 5201 shown in FIG. 74). Thesystem 100 controls the pressure source to cause the flexible membrane5313 to stretch away from the wall 5361 when a more positive pressureexists in the chamber 5309 than the greater of the pressure in the firstchamber 5307 or the pressure in third chamber 5311 (in addition to theforce required to displace the flexible membrane 5313). When a morepositive pressure exists in the second chamber 5309 than in the firstand third chambers 5307, 5311 (in addition to the force required todisplace the flexible membrane 5313), fluid is able to displace theflexible membrane 5313 and create a fluidic connection between chambers5307, 5309 via the holes 5363 through the wall 5361 and the displacedflexible membrane 5313 such that the desired regulated pressure (e.g.,the lesser of the pressure in the first chamber 5307 or the pressure inthe third chamber 5311, in addition to the force required to displacethe flexible membrane 5313) is supplied to the surgical site through theopening 5317 of the second chamber 5309. In nominal conditions, thepressure of the external suction source present in the first chamber5307 is the lower than the pressure of the other chambers 5309, 5311 ofthe pressure regulator 5205, the regulated pressure in the third chamber5311 is greater than the pressure in the second chamber 5309, and theregulated pressure in the third chamber 5311 is adjustable to allowregulation of the pressure supplied to the surgical site through theopening 5317 of the second chamber 5309.

When the first chamber 5307 and the second chamber 5309 are fluidlyconnected, the biohazardous fluid moves from the surgical site, into thesecond chamber 5309 through opening 5317, through the opening betweenthe flexible membrane 5313 and the wall 5361 via holes 5363 and into thefirst chamber 5307, and through the opening 5315 to a waste collectionof the system 100 or the facility. When the valve is desired to beclosed and flow stopped from the surgical site, the system 100 applies apressure more positive in the third chamber 5311 than the maximumpressure expected in the second chamber 5309 (e.g., the pressure causedby the weight of the water column in the height difference between thevalve inlet 5317 and the surgical site) and the pressure in the chamber5307, in addition to the pressure required to displace the flexiblemembrane 5313. When the pressure in chamber 5311 is greater than thepressure in both chambers 5307 and 5309 (in addition to the pressurerequired to displace the flexible membrane), then the flexible membrane5311 is held with sufficient force against wall 5361 to counteract theother system pressures such that flow is substantially halted. Theflexible membrane 5313 seals the third chamber from the first and secondchambers 5307, 5309 to prevent the biohazardous fluid from moving intothe third chamber 5311 and contacting the pressure source and/orpressure sensors of the system 100.

Provided the pressure from the surgical site (as available in chamber5309) is a more positive pressure than the gauge pressure supplied bythe external suction source through the first chamber 5307, the gaugepressure supplied by the pressure source of the system 100 into thethird chamber 5311, and the pressure required to stretch flexiblemembrane 5313, the regulated vacuum pressure supplied to the surgicalsite can be equal to the more-positive gauge pressure of the gaugepressure supplied by the external suction source (through the firstchamber 5307) or the gauge pressure supplied by the pressure source ofthe system 100 (into the third chamber 5311) and the pressure requiredto stretch the flexible membrane 5313. That is, provided the flow ratefrom the surgical site is negligible with respect to the flow capacityof the external pressure source (supplied through the first chamber5307), the pressure supplied to the surgical site (through chamber 5309)will be the pressure closest to absolute vacuum of the pressure suppliedby the external pressure source (through the first chamber 5307) or thepressure supplied by the pressure source of the system 100 (into thethird chamber 5311) and the pressure required to stretch the flexiblemembrane 5313.

In certain embodiments, the pressure required to stretch the flexiblemembrane 5313 may be modeled by a transfer function to determine apressure setpoint for the pressure source of the system 100 (suppliedinto the third chamber 5311) that is required to achieve a desiredregulated vacuum pressure in the second chamber 5309 that is supplied tothe surgical site. The system 100 may be configured to vary theregulated vacuum pressure supplied to the surgical site, via thepressure sensor and pressure pump of the system 100, by varying thepressure supplied to the third chamber 5311. Also, the pressure suppliedby the external suction source (through the first chamber 5307) andsupplied to the second chamber 5309 may be regulated to a more positivepressure by regulating the pressure provided to the third chamber 5311by the pressure source of the system 100 to a greater pressure thansupplied by the external suction source. Because the regulated pressuresetpoint is variable, this also enables the pressure regulator 5205 toserve as a simple 2-way valve to enable and disable flow on demand byregulating the pressure supplied to the third chamber 5311 with apressure greater than the pressure in either the first chamber 5307 orsecond chamber 5309.

In certain embodiments, the flexible membrane 5313 is configured suchthat the pressure supplied by the pressure source in the third chamber5311 causes the flexible membrane 5313 to stretch away from the wall5361 and cause the regulated vacuum pressure supplied to the surgicalsite to be between about 10 mmHg and about 30 mmHg greater than thepressure provided by the pressure source of the system 100. The flexiblemembrane 5313 can be made of, for example, neoprene, silicone, naturalrubber, nitrile, EPDM, other rubber compounds, or any other materialthat allows the flexible membrane to be moved between the engaged anddisengaged positions.

The pressure regulator 5205 may have a housing 5325 that at leastpartially defines the three chambers 5307, 5309, 5311 and includes theopenings 5315, 5317, 5319, 5321. The housing 5325 can be made of, forexample, polycarbonate, any suitable type of plastic material, or anyother suitable material. In certain embodiments, the housing 5325 has afirst component 5327 that includes the first and second chambers 5307,5309, and a second component 5329 that includes the third chamber 5311,where the flexible membrane 5313 is positioned between the first andsecond components 5327, 5329 to fluidly isolate the chambers of thefirst component 5327 from the chambers of the second component 5329. Thefirst component 5327, the second component 5329, and the flexiblemembrane 5313 can be connected by a snap-fit connection, an adhesiveconnection, one or more fasteners, laser welding, ultrasonic welding,vibration welding, or any other suitable means.

Referring to the embodiment shown in FIG. 53, if the lowest desiredregulated pressure supplied to the surgical site is a positive gaugepressure, the pressure supplied by the external pressure source could bea positive or negative gauge pressure. If the desired regulated pressureis a negative gauge pressure (i.e., a vacuum pressure), then thepressure supplied by the external suction source may be required to be anegative gauge pressure that is more negative than the lowest gaugepressure desired to be regulated because pressure supplied by theexternal pressure source is not being sensed. In other words, thepressure supplied by the external pressure source (through the firstchamber 5307) is not required to be consistent (e.g., does not need tobe regulated and may have pressure fluctuations) provided the highestgauge pressure supplied by the external pressure source is not a gaugepressure that is higher than the desired regulation pressure setpointfor the regulated source (e.g., the surgical site).

Although the embodiment of the pressure regulator 5205 shown in FIG. 53is effective for regulating an external suction source that provides avacuum level that is known to be more-negative than the desiredregulated vacuum pressure provided to the surgical site, a secondembodiment of the pressure regulator 5205 (shown in FIGS. 54-73) allowsthe fluid management system 100 to regulate an external suction sourcethat is providing an unknown or variable vacuum level and sense when thevacuum level is sufficient to achieve the desired regulation setpoint.Referring to FIGS. 54 and 55, the second embodiment of the pressureregulator 5205 utilizes two valves of the first embodiment (FIG. 53)arranged in series.

Referring to FIG. 54, the second exemplary embodiment of the pressureregulator 5205 includes four chambers 5407, 5409, 5411, 5412 and aflexible membrane 5413. The first chamber 5407 includes an opening orport 5415 for fluidly connecting to the external suction source. Thesecond chamber 5409 has an opening or port 5417 for fluidly connectingto the surgical site (via one or more fluid lines or tubes). The thirdchamber 5411 includes one or more ports 5419 for connecting to apressure source (e.g., pressure source 7449 of aspiration module 5201shown in FIG. 74), and the fourth chamber 5412 includes one or moreopenings 5421 for connecting to one or more pressure sensors (e.g.,pressure sensors 7451 of aspiration module 5201 shown in FIGS. 74-75).Alternative embodiments can incorporate sensors from the same portconnections of the pressure regulator 5205 for redundancy or improvedregulation of the pressure source.

The flexible membrane 5413 is positioned to fluidly isolate (i.e., seal)each of the third and fourth chambers 5411, 5412 from both of the firstand second chambers 5407, 5409, which allows the pressure source andpressure sensor of the fluid management system 100 to be fluidlyisolated from biohazardous fluid returning from the surgical site andmoving through the first and second chambers 5407, 5409. The firstchamber 5407 is adjacent to the second chamber 5409 and separated fromthe second chamber 5409 by a vertical extended member or wall 5423 and ahorizontal extended member or wall 5465. The wall 5465 includes openings5467 that fluidly connect the first chamber 5307 to the second chamber5309. The flexible membrane 5413 is movable from an engaged position andone or more disengaged positions with the wall 5465, where the first andsecond chambers 5407, 5409 are fluidly isolated from each other when theflexible membrane 5413 is in the engaged position, and where the firstand second chambers 5407, 5409 are fluidly connected with each other(via openings 5467) when the flexible membrane 5413 is in the disengagedposition. The third chamber 5411 is adjacent to the fourth chamber 5412and separated from the first chamber 5412 by a vertical extended memberor wall 5431 and a horizontal extended member or wall 5461. The wall5461 includes openings 5463 that fluidly connect the third chamber 5411to the fourth chamber 5413. The flexible membrane 5413 is also movablefrom an engaged position and one or more disengaged positions with thewall 5461, where the third and fourth chambers 5411, 5412 are fluidlyisolated from each other when the flexible membrane 5413 is in theengaged position, and where the third and fourth chambers 5411, 5412 arefluidly connected with each other (via openings 5463) when the flexiblemembrane 5413 is in the disengaged position.

To better show that the embodiment of the pressure regulator 5205 shownin FIG. 54 utilizes two valves of the first embodiment of the pressureregulator shown in FIG. 53 in series, the first chamber 5407 is shown ashaving a first portion 5408 and a second portion 5410, but the pressureacross both the first and second portions 5408, 5410, as supplied by theexternal suction source, is identical (as there is no barrier capable ofsealing the first and second portions 5408, 5410 from each other).Referring to FIG. 55, the first valve 5501 of the pressure regulator5205 utilizes the external suction source (via the first portion 5408 ofthe first chamber 5407) to regulate movement of the pressure supplied bythe pressure source of the fluid management system from the thirdchamber 5411 to the fourth chamber 5412. The second valve 5503 utilizesthe pressure in the fourth chamber 5412 (via the movement of pressurefrom the third chamber 5411 to the fourth chamber 5412) to regulate themovement of the pressure supplied by the external suction source fromthe second portion 5410 of the first chamber 5407 to the second chamber5409 such that the pressure in the second chamber 5409 is substantiallyequal to the desired regulated vacuum pressure at the surgical site.

Referring to FIGS. 54 and 55, the pressure at the first portion 5408 ofthe first chamber 5407 causes the flexible membrane 5413 to be in eitherthe engaged position or the disengaged position with the wall 5461. Forexample, if the vacuum pressure supplied by the external suction sourceis more negative than the pressure supplied by the pressure source ofthe system 100 into the third chamber 5411, the flexible membrane 5413stretches away from the wall 5461 such that the third and fourthchambers 5411, 5412 are fluidly connected. When the third and fourthchambers 5411, 5412 are fluidly connected, the pressure in the fourthchamber 5412 is substantially equal to the pressure in the third chamber5411. Comparatively, if the vacuum pressure supplied by the externalsuction source is more positive than the pressure supplied by thepressure source into the third chamber 5411, the flexible membrane is inthe engaged position with the wall 5461 to fluidly isolate the fourthchamber 5412 from the third chamber 5411.

The fluid management system 100 senses the pressure within the fourthchamber 5412 via the one or more pressure sensors of the system 100,which allows the system 100 to determine if the pressure supplied by theexternal suction source is not supplying sufficient vacuum pressure tomeet the desired regulated vacuum pressure at the surgical site. Thatis, if the external suction source is not supplying enough pressure tocause the flexible membrane 5413 to stretch away from the wall 5461, airwill slowly bleed out of the fourth chamber 5412 via a small orifice orvalve of the system 100 that may be constantly or periodically opened toa more positive gauge pressure to gradually bring the pressure in thefourth chamber 5412 closer to this more positive gauge pressure, and thepressure sensor of the system 100 will sense that the pressure in thefourth chamber 5412 is not equal to the pressure supplied by thepressure source to the third chamber 5411, which will cause the systemto determine that the pressure supplied by the external suction sourceis not sufficient to meet the desired regulated vacuum pressure at thesurgical site. The pressure sensed by the system 100 in the fourthchamber 5412, given enough time to bleed off pressure, can be used todetermine the actual pressure present in the first chamber 5407 if it isless than the positive gauge pressure that is slowly bled into thefourth chamber 5412. If the system 100 determines that the externalsuction source is not supplying a sufficient vacuum pressure, the system100 may be configured to notify the user to adjust the external pressuresource (e.g., by increasing the suction setting of external pressuresource, unclogging the line leading to the external pressure source,finding a leak in the line leading to the external pressure source,etc.) to ensure it is sufficient to down-regulate the vacuum pressure atthe surgical site to the desired regulated vacuum pressure.

Referring to FIGS. 54 and 55, the second valve 5503 of the pressureregulator 5205 utilizes the pressure supplied by the pressure source ofthe fluid management system in the fourth chamber 5412 to regulate themovement of pressure supplied by the external suction source to thesecond chamber 5409 and, consequently, the surgical site. That is, thesystem 100 controls the pressure source to cause the flexible membrane5413 to stretch away from the wall 5465 to fluidically connect the firstand second chambers 5407, 5409 such that the desired regulated vacuumpressure is supplied to the surgical site through the opening 5417 ofthe second chamber 5409. The biohazardous fluid then moves from thesurgical site, into the second chamber 5409 through opening 5417,through the openings 5467 between the flexible membrane 5413 the wall5465 and into the first chamber 5407, and through the opening 5415 to awaste collection of the system 100 or the facility. The flexiblemembrane 5413 seals each of the third and fourth chambers 5411, 5412from both of the first and second chambers 5407, 5409 to prevent thebiohazardous fluid from contacting the pressure source and/or pressuresensors of the system 100.

Provided the pressure from the surgical site as available in chamber5409 is a more positive pressure than both the gauge pressure suppliedby the external suction source (through the first chamber 5407) and thegauge pressure supplied by the pressure source of the system 100 (intothe third chamber 5411) and the pressure required to stretch flexiblemembrane 5413, the regulated vacuum pressure supplied to the surgicalsite can be equal to the more-positive gauge pressure of the gaugepressure supplied by the external suction source (through the firstchamber 5407) or the gauge pressure supplied by the pressure source ofthe system 100 (into the third and fourth chambers 5411, 5412) and thepressure required to stretch the flexible membrane 5413. That is,provided the flow rate from the surgical site is negligible with respectto the flow capacity of the external pressure source (supplied throughthe first chamber 5407), the pressure supplied to the surgical site(through chamber 5409) will be the pressure closest to absolute vacuumof the pressure supplied by the external pressure source (through thefirst chamber 5407) and the pressure required to stretch the flexiblemembrane 5413 or the pressure supplied by the pressure source of thesystem 100 (into the third and fourth chambers 5411, 5412) and thepressure required to stretch the flexible membrane 5413.

In certain embodiments, the pressure required to stretch the flexiblemembrane 5413 may be modeled by a transfer function to determine apressure setpoint for the pressure source of the system 100 (suppliedinto the third and fourth chambers 5411, 5412) that is required toachieve a desired regulated vacuum pressure in the second chamber 5409that is supplied to the surgical site. The system 100 may be configuredto vary the regulated vacuum pressure supplied to the surgical site, viathe pressure sensor and pressure pump of the system 100, by varying thepressure supplied to the third and fourth chambers 5411, 5412. Also, thepressure supplied by the external suction source (through the firstchamber 5407) and supplied to the second chamber 5409 may be regulatedto a more positive pressure by regulating the pressure provided to thethird and fourth chambers 5411, 5412 by the pressure source of thesystem 100 to a greater pressure than supplied by the external suctionsource. Because the regulated vacuum pressure setpoint is variable, thisalso enables the pressure regulator 5205 to serve as a simple 2-wayvalve to enable and disable flow on demand by regulating the pressuresupplied to the third and fourth chambers 5411, 5412 with a pressuregreater than the pressures in either the first chamber 5407 or secondchamber 5409.

In certain embodiments, the flexible membrane 5413 is configured suchthat the pressure supplied by the pressure source in the third andfourth chambers 5411, 5412 causes the flexible membrane 5413 to stretchaway from the wall 5423 and cause the regulated vacuum pressure suppliedto the surgical site to be between about 10 mmHg and about 30 mmHggreater than the pressure provided by the pressure source of the system100, such as about 20 mmHg greater than the pressure provided by thepressure source. The flexible membrane 5413 can be made of, for example,neoprene, silicone, natural rubber, nitrile, EPDM, other rubbercompounds, or any other material that allows the flexible membrane to bemoved between the engaged and disengaged positions.

In certain embodiments, the fourth chamber 5412 is pneumaticallyattached to a small orifice or valve of the fluid management system 100that may be constantly or periodically opened to bleed off pressure to agauge pressure that is greater than or equal to the maximum gaugepressure expected from either the pressure source of the fluidmanagement system 100 or the external suction source. The opened orificeor valve bleeds off pressure at a negligible flow rate compared to theflow rate capability of the pressure source of the fluid managementsystem to ensure that the pressure inside of the fourth chamber 5412 isthe greater gauge pressure of the external pressure source or thedesired regulated pressure in the second chamber 5409 and any additionalforce required to stretch or open the flexible membrane 5413.

The embodiment of the pressure regulator 5205 shown in FIGS. 54 and 55allows for non-wetted, indirect sensing of the pressure source of thefluid management system 100 to help ensure that the external suctionsource is of sufficient pressure to regulate to the desired vacuumpressure of the system's pressure source to down-regulate the vacuumpressure in the second chamber 5409 and at the surgical site. Being ableto indirectly sense the pressure supplied by the external suction sourcevia the cost-effective single use pressure regulator 5205 is beneficialbecause it enables the system 100 to prompt the user to adjust theexternal suction source (by increasing the suction setting of theexternal suction source, unclogging the line leading to the externalsuction source, finding a leak in the line leading to the externalsuction source, etc.) to ensure it is sufficient to down-regulate thevacuum pressure at the surgical site to the desired regulated vacuumpressure or otherwise prevent operation of the system if the regulatedvacuum pressure levels would be detrimental to the safety or efficacy ofthe intended use of the regulated vacuum pressure from the system.

FIGS. 56 through 64 show an embodiment of the pressure regulator 5205shown in FIGS. 54 and 55. In the illustrated embodiment, the pressureregulator 5205 includes a housing 5625 that at least partially definesthe four chambers 5407, 5409, 5411, 5412 and includes the openings 5415,5417, 5419, 5421. The housing 5625 can be made of, for example,polycarbonate or any other suitable material. Referring to FIG. 58, incertain embodiments, the housing 5625 has a first component 5827 thatincludes the first and second chambers 5407, 5409, and a secondcomponent 5829 that includes the third and fourth chambers 5411, 5412.The first and second components 5827, 5829 can be, for example,injection molded pieces. The flexible membrane 5413 is positionedbetween the two components 5827, 5829 to fluidly isolate the chambers5407, 5409 of the first component 5827 from the chambers 5411, 5412 ofthe second component 5829. In some embodiments, the pressure regulator5205 may also include covers 5833 for covering the outer facing portionsof the chambers for each component 5827, 5829. The first component 5827,the second component 5829, the flexible membrane 5413, and the covers5833 can be connected by a snap-fit connection, an adhesive connection,one or more fasteners, ultrasonic welding, combinations thereof, or anyother suitable means. In some embodiments, the pressure regulator 5205may include one or more hydrophobic filters 5835 for helping maintain abacterial barrier between the pressure source and pressure sensors ofthe fluid management system 100.

Referring to FIG. 64, in certain embodiments, the pressure regulator5205 shown in FIGS. 56-63 can be used in combination with an aspirationmodule (e.g., aspiration module 7404 shown in FIGS. 74-75) that includesa pressure pump (e.g., pressure pump 7449 shown in FIG. 74) and pressuresensors (e.g., pressure sensors 7451 shown in FIGS. 74-75) to sense andregulate the external suction source to control the rate of fluidoutflow from a surgical site. When the pressure regulator is insertedinto the aspiration module, the pressure regulator 5205 may beconfigured to connect to a receiving mechanism 6437 (FIG. 64) thatautomatically connects the port 5419 for the third chamber 5411 to aport 6439 that is operatively connected to the pressure pump of theaspiration module. The connection between the pressure regulator 5205and the receiving mechanism may also automatically connect the port 5421for the fourth chamber 5412 to a port 6441 that is operatively connectedto sensors and or an air bleed mechanism of the aspiration module. Theconnection mechanism 6437 may include channels 6443 for receiving endportions 6445 of the pressure regulator 5205 to allow for a secureconnection between the pressure regulator 5205 and the aspirationmodule. After inserting the pressure regulator into the aspirationmodule 5205, the user can manually connect the external suction sourceto the port 5415 for the first chamber 5407 and manually connect thefluid return lines from the surgical site to the port 5417 for thesecond chamber 5409.

FIGS. 65 through 73 show another embodiment of the pressure regulator5205 shown in FIGS. 54 and 55. In the illustrated embodiment, thepressure regulator 5205 includes a housing 6525 that at least partiallydefines the four chambers 5407, 5409, 5411, 5412 and includes theopenings 5415, 5417, 5419, 5421. The housing 5625 can be made of, forexample, polycarbonate or any other suitable material. In certainembodiments, the housing 6525 has a first component 6829 that includesthe first and second chambers 5407, 5409, and a second component 6827that includes the third and fourth chambers 5411, 5412. The first andsecond components 6827, 6829 can be, for example, injection moldedpieces. The flexible membrane 5413 is positioned between the twocomponents 6827, 6829 to fluidly isolate the chambers 5407, 5409 of thefirst component 6827 from the chambers 5411, 5412 of the secondcomponent 6829. In some embodiments, the pressure regulator 5205 mayalso include covers 6633 for covering the outer facing portions of thechambers for each component 6827, 6829. The first component 6827, thesecond component 6829, the flexible membrane 5413, and the covers 6533,6633 can be connected by a snap-fit connection, an adhesive connection,one or more fasteners, ultrasonic welding, combinations thereof, or anyother suitable means. In some embodiments, the pressure regulator 5205may include one or more hydrophobic filters 6635 for helping maintain abacterial barrier between the pressure source and pressure sensors ofthe fluid management system 100. The pressure regulator 5205 can alsoinclude one or more sealing members 6643 (e.g., O-rings) for makingfluid tight connections. In certain embodiments, the housing 6525 has agripping member or handle 6547 that helps a user insert and remove thepressure regulator from the aspiration module or other component of thefluid management system 100.

Referring to FIGS. 72 and 73, in certain embodiments, the pressureregulator 5205 shown in FIGS. 65-71 can be used in combination with anaspiration module (e.g., aspiration module 7404 shown in FIGS. 74-75)that includes a pressure pump (e.g., pressure pump 7449 shown in FIG.74) and pressure sensors (e.g., pressure sensors 7451 shown in FIGS.74-75) to sense and regulate the external suction source to control therate of fluid outflow from a surgical site. When the pressure regulator5205 is inserted into the aspiration module, the pressure regulator 5205may be configured to connect to a receiving mechanism 7237 thatautomatically connects the port 5419 for the third chamber 5411 to aport 6439 that is operatively connected to the pressure pump of theaspiration module. The connection between the pressure regulator 5205and the receiving mechanism may also automatically connect the port 5421for the fourth chamber 5412 to a port 7241 that is operatively connectedto sensors and or an air bleed mechanism of the aspiration module. Theconnection mechanism 6437 may include channels (not shown) for receivingend portions of the pressure regulator 5205 to allow for a secureconnection between the pressure regulator 5205 and the aspiration module(e.g., similar to as shown in the embodiment shown in FIG. 64). Afterinserting the pressure regulator into the aspiration module 5205, theuser can manually connect the external suction source to the port 5415for the first chamber 5407 and manually connect the fluid return linesfrom the surgical site to the port 5417 for the second chamber 5409.

FIGS. 74 and 75 illustrate an exemplary embodiment of the aspirationmodule 5201 that can be used with the fluid management system 100 shownin FIG. 1 and the various embodiments of the pressure regulators 5205shown in FIGS. 53-73. The aspiration module 5201 may include thereceiving mechanism 7437 (e.g., receiving mechanism 6437 shown in FIG.64 or receiving mechanism 7237 shown in FIG. 72) for receiving thepressure regulator 5205, an integrated pressure pump 7449, one or morevalves 7452, 7453 for connecting the pressure pump to the pressureregulator 5205, and a printed circuit board (PCB) 7448 having one ormore pressure sensors 7451.

The integrated pressure pump 7449 may be configured to supply a positivepressure or a negative pressure to the pressure regulator 5205 viaopening 5419 (FIG. 54) of the pressure regulator. For example, the pump7449 may be an air pump that includes two ports (not shown), and theaspiration module 5201 may include valves 7452, 7453 (e.g., three-wayvalves) connected to the opening 5419 of the pressure regulator 5205 andthe ports of the pump 7449. A first port of the pump 7449 may beconfigured to pull air into the pump 7449, and a second port of the pump7449 may be configured to push air out of the pump, which allows thepump 7449 to supply both positive and negative pressures for pressureregulation and stoppage of flow through the valves. For example, if theport which pulls air into the pump 7449 is left open to ambient and theport which pushes air out of the pump 7449 is connected to asubstantially sealed vessel, then the pump 7449 will build up positivepressure inside the substantially sealed vessel. Conversely, if the portwhich pushes air out of the pump 7449 is left open to ambient and theport which pulls air into the pump 7449 is connected to a substantiallysealed vessel, then the pump 7449 will build up vacuum pressure insidethe substantially sealed vessel. In this embodiment, the valves 7452,7453 are ported such that the pump ports can each be opened to ambientair pressure and connected to supply pressure to the aspiration module.Software of the control system may modulate the states of the valves7452, 7453 to configure the pump to supply positive or vacuum pressureto the system based on the desired valve state and regulation setpoint.The pump 7449 can be fluidly connected to the valves 7452, 7453 bytubing. In other embodiments, the pump 7449 may be configured to supplyeither a positive pressure or a negative pressure to the pressureregulator, or the aspiration module 5201 may include separate positiveand negative pressure pumps for supplying pressure to the pressureregulator 5205. In certain embodiments, an accumulator 7450 is fluidlypositioned between pressure pump 7449 and the pressure regulator 5205 toaid in regulating the pressure provided to the pressure regulator 5205by the pressure pump 7449.

The one or more pressure sensors 7451 may be used to monitor both thepressure supplied to third chamber 5411 (FIG. 54) of the pressureregulator 5205 by the pressure pump 7449 and a pressure within thefourth chamber 5412 (FIG. 54) of the pressure regulator 5205. In certainembodiments, the pressure sensors 7451 can be operatively connected tothe accumulator 7450 by pneumatic tubing to monitor the pressuresupplied to the pressure regulator 5205, and the pressure sensors 7451can be operatively connected to the opening 5421 (FIG. 54) of thepressure regulator 5205 by pneumatic tubing to monitor the pressurewithin the fourth chamber 5412. The pressure sensors 7451 allow thefluid management system 100 to sense the pressure within the fourthchamber 5412 (FIG. 54) of the pressure regulator 5205 to determine ifthe pressure supplied by the external suction source that is connectedto the first chamber 5407 (FIG. 54) is not supplying sufficient vacuumpressure to meet the desired regulated vacuum pressure at the surgicalsite.

Referring to FIG. 75, in certain embodiments, the aspiration module 5201includes a valve 7554 that allows for the fourth chamber 5412 (FIG. 54)of the pressure regulator 5205 to be constantly or periodically openedto bleed off pressure to a gauge pressure that is greater than or equalto the maximum gauge pressure expected from either the pressure pump7449 (FIG. 74) or the external suction source. The opened orifice orvalve bleeds off pressure at a negligible flow rate compared to the flowrate capability of the pressure pump 7449 to ensure that the pressureinside of the fourth chamber 5412 (FIG. 54) is the greater gaugepressure of the external pressure source or the desired regulatedpressure supplied to the surgical site.

Referring to the operation of the fluid management system 100 discussedin the present application, the control system may be configured toguide the user through the setup process using, for example,instructions, illustrations, animations, video, and/or system feedbackvia the user interface 110. Referring to FIGS. 76 and 77, in certainembodiments, the system 100 prompts a user (via the user interface 110)to select the surgical discipline and procedure that will be performed,which can cause the system 100 to set default operating parameters forthe procedure, as well as safe, permissible adjustment ranges for thoseparameters (as stored in a memory of the system 100). For example, thesystem 100 may prompt a user to select a discipline of “Gynecology,”“Urology,” or “Orthopedic”; and, if the user selects “Urology,” thesystem 100 may prompt the user to select one of the followingprocedures: “Cystoscopy,” “PCNL,” “TURBT,” “TURP,” or “Ureteroscopy.”Based on the selection by the user, the system 100 may then set defaultoperating parameters (e.g., pressure control mode or flow control mode,setpoint fluid pressure or flow rate, fluid warming condition enabled ordisabled, fluid deficit monitoring enabled or disabled, etc.) for theprocedure.

In certain embodiments, the system 100 may provide instructions to auser for installing the tubing sets to the various components of thesystem 100. For example, the system 100 may instruct the user to insertthe cartridge assembly 419 (FIG. 4) that includes the fluid conditioner420 (FIG. 4) and fluid warming cartridge 422 (FIG. 4) into the main unit102, and then place or route the tubing that connects the fluid supplycontainers and the cartridge assembly 419 into or through the pump 212(FIG. 2). The system 100 may then prompt the user to indicate whetherfluid deficit monitoring will be performed during the procedure. Incertain situations, the system 100 may require fluid deficit monitoringbe performed based on an input from the user as to the type of procedurethat is being performed. For example, if the user selects an operativehysteroscopy procedure, fluid deficit monitoring is required. For othergynecological and urological procedures, fluid deficit monitoring may beoptional. If the user did not select an operative hysteroscopy procedureand did not elect to enable fluid deficit monitoring for the selectedprocedure, the system 100 may instruct the user to spike and hang thefluid bags. If the user selected an operative hysteroscopy, or selectedanother procedure and elected to enable fluid deficit monitoring featurefor the selected procedure, the system 100 may prompt the user toindicate whether one or more fluid types will be used during theprocedure and what the fluid types are, as illustrated FIGS. 78 through80.

In various embodiments, the system 100 may be configured to monitor anddisplay fluid deficit by fluid type. For example, in operativehysteroscopy, surgeons can utilize multiple fluid types during aprocedure based on the type of procedure being performed and thesurgical instruments employed. These fluids can differ in osmolality,electrolyte content, and viscosity. The amount of these fluids absorbedby the surgical patient depend on the fluid pressure, the length of theprocedure, and the degree of surgical disruption of the venous sinusesin the endometrium and, importantly, the myometrium if the intrauterinefluid pressure is greater than the surgical patient's mean arterialpressure. Thus, the capability of monitoring and displaying fluiddeficit by fluid type enhances the safety for the patient.

Referring to FIGS. 78-80, after the user indicates the number of fluidtypes that will be used during the procedure, the system 100 may promptthe user (via the user interface 110) to select the specific fluids willbe used during the procedure. The system 100 may then set the maximumallowable deficit limit for each specific fluid type (based oninformation stored in a memory of the control system or based oninformation inputted by a user). For example, the maximum allowabledeficit limit for hypotonic, electrolyte-free fluids may be 1000 ml, andthe maximum allowable deficit limit for isotonic, electrolyte containingfluids may be 2500 ml. The system 100 may also set a maximum totaldeficit limit for the procedure based on a sum of the fluid deficits forthe selected fluid types. For example, the maximum total deficit limitfor the procedure may be 2,500 ml.

In various embodiments, the system 100 will provide a user withinstructions (via the user interface 110) for hanging the fluid supplycontainers. For example, with regards to a first fluid type selected bythe user, the system 100 may instruct the user as to which hangingmembers 116 (FIGS. 1 and 2) to use, instruct the user to hang the fluidsupply container(s) and then monitor the hanging member(s) 116 (FIGS. 1and 2) to confirm that the fluid supply container(s) were disposed onthe correct hanging members, or prompt the user to indicate whichhanging member(s) 116 (FIGS. 1 and 2) will be used to hold the fluidsupply container(s) and then monitor the weight of the hanging member(s)116 (e.g., via load cells connected to the hanging members) to determinewhen the fluid container(s) are disposed on the corresponding hangingmembers 116. The system 100 can then repeat the above process for thefluid container(s) holding the second fluid type.

During the procedure, the system 100 may be configured to monitor anddisplay the fluid deficit level for the first fluid type (via the userinterface 110) by subtracting an amount of fluid returned from thesurgical site (e.g., as determined using the deficit cartridge 2010 anddeficit module 104 or by monitoring a weight of fluid collectioncontainers hanging from member(s) 116 (FIGS. 1 and 2), etc.) from thevolume of fluid pumped to the surgical site (e.g., as determined bymonitoring the weight of the fluid supply containers, monitoring theamount of pump rotations of the pump 212, etc.).

In certain embodiments, the user can switch to the second fluid type viathe user interface 110 (e.g., by pressing a “Change Fluid Type” buttonor other similar button). The system 100 may then instruct the user toclose the tubing line(s) connecting the fluid supply containers for thefirst fluid type to the pump 212 (e.g., by closing clamp(s) on thetubing line(s)). The system 100 may also instruct the user to collectall residual fluid of the first fluid type from the surgical site,underbody drape, and the floor. Subsequently, the system 100 mayinstruct the user to fluidly connect the tubing lines of the fluidsupply containers for the second fluid type (e.g., by opening clamp(s)on the tubing line(s)). In alternative embodiments, the system 100 maybe configured to detect (via one or more processors of the controlsystem) when a user switches to the second fluid type. In certainembodiments, the tubing lines may be automatically fluidly connected ordisconnected by pinch valves.

After fluidly connecting the tubing lines for the second fluid type, theuser may initiate a purge of the first fluid type from the system 100.In certain embodiments, the user will stop the pump, remove the scopeand/or surgical instrument from the body cavity constituting thesurgical site, and allow the cavity to drain the first fluid type intothe underbody drape. When complete, the user will fluidly disconnect thefirst fluid type from the pump by closing the associated clamp(s),fluidly connect the second fluid type to the pump by opening theassociated clamp(s), direct the scope and/or surgical instrument intothe underbody drape and press a “Purge” or similar button on the userinterface 110 of system 100 which will cause the system 100 to pump thevolume of the second fluid type necessary to force the first fluid typefrom the cartridge assembly 419, fluid inflow tube, and scope and/orinstrument. In certain embodiments, system 100 may pump the second fluidtype necessary to cause the purge until the user presses a “Stop Purge”or similar button on the user interface 110 of system 100. After thepurge has been completed and the underbody drape has emptied, system 100will record the fluid deficit for the first fluid type, empty thedeficit cartridge 2010 (FIGS. 33-34), and then indicate to the user viauser interface 110 of system 100 that the procedure can proceed with thesecond fluid type. This process may be repeated to change back and forthbetween the first and second fluid types.

After the first fluid type is purged from the system 100, the system 100may commence monitoring and display of the fluid deficit level for thesecond type of fluid. The system 100 may be configured to display thetotal fluid deficit, the deficit of the first fluid type, and/or thedeficit of the second fluid type. In certain embodiments, a user may beable to elect, via a toggle switch or similar button on the userinterface 100, whether the system 100 displays the total fluid deficit,the deficit of the first fluid type, the deficit of the second fluidtype, and/or any combination thereof.

In some embodiments, if the user does not notify the system 100 of afluid change (i.e., the change from the first fluid to the secondfluid), the system 100 may stop the pump 212 to pause fluid flow. Forexample, the system 100 may prompt the user to indicate whether a changein fluid type was intended, and, if the user indicates that a change influid type was not intended, the system can instruct the user to checkfor any issues that may be affecting the weight on a hanging memberassociated with the other fluid type (e.g., such as leakage from the bagor an open or partially open clamp). If the user indicates that a changein fluid type was intended, the system 100 can instruct the user toinitiate a purge of the system (as indicated above). The user may switchthe fluids multiple times using the procedures described herein.

In certain embodiments, a user that initially indicated only one fluidwould be used in the procedure, may during the procedure, indicate tosystem 100 via user interface 110 that a second fluid will be used bypressing a “Settings” button or icon or similar button or icon on theuser interface 110 and then pressing an “Add Second Fluid” button oricon or similar button or icon. The system 100 may then instruct theuser via user interface 110 to hang the second fluid type, purge thefirst fluid type, record the deficit for the first fluid type, andinstruct the user to continue the procedure using the second fluid typeas indicated above. The system can then track the deficit for the firstfluid type, the second fluid type, and total deficit.

In certain embodiments, once the fluid containers have been placed onthe hanging members 116, the system 100 may guide the user to completethe tubing installation process. For example, if the fluid suction andcollection module 106 is utilized, but the deficit module 104 is notutilized, the instructions can include connecting the fluid linesreturning from the surgical site, underbody drape, and the floor (ifapplicable) to the fluid suction and collection module 106. If thedeficit module 104 is utilized, the instructions can include insertingthe deficit cartridge 2010 into the deficit module 104, connecting thesuction source to the deficit cartridge 2010 (e.g., via vacuum port2016), and connecting the fluid return tubing lines (from the surgicalsite) to the deficit cartridge 2010 (e.g., via fluid inlet ports 2012,2014). If the aspiration module 5201 is utilized, the instructions caninclude inserting the pressure regulator 5205 into the aspiration module5201, connecting the suction source to the pressure regulator 5205(e.g., via port 5315 shown in FIG. 53 or port 5415 shown in FIGS.54-55), and connecting the fluid return tubing lines (from the surgicalsite) to the pressure regulator 5205 (e.g., via port 5317 shown in FIG.53 or port 5417 shown in FIGS. 54-55). If the fluid flow and evacuationmodule 5101 (FIG. 51) is utilized, the instructions can includeinserting the deficit cartridge 2010 (or similar single-use fluid volumemonitoring cartridge) into the fluid flow monitoring and evacuationmodule 5101 and connecting the fluid return tubing lines (from thesurgical site) to the deficit cartridge (e.g., via fluid inlet ports2012, 2014).

Following the tubing installation process, the system 100 may instructthe user to complete a priming process. For example, the system 100 mayinstruct the user to fluidly disconnect the fluid conditioner 420 (FIG.10) from the surgical instrument being used at the surgical site (e.g.,by closing a clamp on the tubing that connects the fluid conditioner 420to the surgical instrument). The system 100 may also instruct the userto fluidly connect at least one of the fluid supply containers to thepump 212 (e.g., by opening a clamp on the tubing that connects the fluidsupply container to the pump 212). Subsequently, the system 100 mayinstruct the user to initiate priming of the tubing set (e.g., bypressing a “Prime” button or other similar button), which will cause thesystem 100 to pump fluid from the at least one fluid container and intothe fluid conditioner 420 until the pressure sensors of the system 100indicate that fluid in the fluid outlet chamber 1054 (FIG. 10) of thefluid conditioner 420 has reached a certain fluid pressure, and/or untila fluid presence sensor (e.g., fluid presence sensor 948 shown in FIG.9) of the system 100 that targets the fluid outlet chamber 1054indicates that the fluid has reached a certain level. After the system100 determines that the pressure or fluid level in the outlet chamber1054 is sufficient, the system 100 may stop the pump 212. The fluidpressure within the outlet chamber 1054 may then be reduced by reversingthe pump 212 or opening a solenoid valve (e.g., solenoid valve 951 shownin FIG. 9) until the desired fluid pressure or fluid level in the outletchamber 1054 of the fluid conditioner 420 has been achieved. The volumeof fluid necessary to prime the tubing set may be known and added as aconstant offset for the purposes of monitoring and displaying the volumeof fluid pumped and the fluid deficit (if applicable).

Referring to FIG. 81, the system 100 may include a procedure run screen8101 (via the user interface 110). In the illustrated embodiment, theprocedure run screen 8101 is shown for a system that is in pressurecontrol mode. In alternative embodiments, the system 100 may be in flowcontrol mode or flex control mode. Each of these control modes arediscussed in more detail below. The user may start a procedure bypressing the “Play”, “Run”, or similar icon or button 8103 in thenavigation bar at the bottom of the screen 8101. The user may also, viaadjustment control/buttons on the run screen 8101, change defaultoperating settings, such as, for example, the fluid pressure setpointcondition 8105 (if the system 100 is in a pressure control mode), thefluid flow rate setpoint condition (not shown—if the system 100 is in aflow control mode), and the deficit alarm level 8107 (if the deficitmonitoring function is required or has been elected). In certainembodiments, the system 100 may only allow a user to change the defaultoperating settings to be within the safe, permissible adjustment ranges8111 for the procedure. The procedure run screen 8101 may also allow auser to enable/disable the fluid warming function by using switch 8113and display the fluid temperature 8112.

In addition to displaying an actual condition 8115 and setpointcondition 8105 for pressure (or for flow if the system 100 is in a flowcontrol mode), and an actual condition 8117 and setpoint condition 8107for fluid deficit (if applicable), the procedure run screen 8101 mayalso display other information. For example, the procedure run screen8101 may display fluid inflow or volume pumped 8121 to the surgicalsite, the fluid flow rate 8123 (if the system 100 is in pressure controlmode), and/or the fluid pressure (not shown—if the system 100 is in flowcontrol mode). The procedure run screen 8101 may also have a navigationbar consisting of icons or buttons that can be used before or during theprocedure, such as, for examples, a “Settings” button 8128, a “Help” or“Troubleshooting” button 8127, a “Notifications” button 8129, a“Maintenance” button 8181, and/or an “End Case” or “End Procedure”button 8133.

In certain embodiments, pressing the “Settings” button 8128 brings up asettings screen (not shown) on the user interface 110 that allows theuser to adjust, set, or enable other features of the system 100. Forexample, referring to FIG. 82, the system 100 may include a proceduresettings screen 8202 that allows a user to set or adjust the controlmode that the system 100 will follow for the procedure. In thisembodiment, the system 100 may be set in a pressure control mode 8204, aflow control mode 8206, or a flex control mode 8208. In certainembodiments, the system 100 may default to one of the control modes(e.g., the pressure control mode 8204), but the user can change the typeof control mode in the procedure settings screen 8202. If the system 100is in flow control mode 8206, the system varies the speed of the pump212 to achieve and maintain a user-selected fluid flow rate setpoint(e.g., as set by the user on the procedure run screen 8101) provided,however, that the maximum allowable fluid pressure for the procedurecannot be exceeded. In other words, the fluid pressure is varied toachieve the desired fluid flow rate.

If the system 100 is in pressure control mode 8204, the system 100varies the speed of the pump 212 to achieve and maintain a user-selectedfluid pressure setpoint (e.g., as set by the user on the procedure runscreen 8101 shown in FIG. 81) provided, however, that the maximumallowable fluid flow rate for the procedure cannot be exceeded. In otherwords, the fluid flow rate is varied to achieve the desired fluidpressure. In some embodiments, the system 100 can control to theuser-selected fluid pressure setpoint as the desired fluid pressure atthe system. In some embodiments, the system 100 can control to theuser-selected fluid pressure setpoint as the desired fluid pressure atthe surgical scope or instrument. Referring to FIG. 81A, for ergonomicreasons corresponding to operating the graphical user interface 110,hanging fluid supply containers from hanging members 116, and insertingcomponents (e.g., the cartridge assembly 419 and/or deficit cartridge2010 described in the present application) into the main unit 102, aheight H1 of main unit 102 may be higher than the surgical table 8151.In certain embodiments, the system 100 can compensate for the headpressure resulting from the difference H3 between the height H1 of themain unit 102 and the assumed or inputted height H2 of a patient 8153 incalculating the required system pressure. That is, the system 100 canequate the compensation height H3 to a pressure adjustment, and thensubtract the pressure adjustment from the user-selected fluid pressuresetpoint at the surgical scope or instrument. In some embodiments, thesystem 100 can control to the user-selected fluid pressure setpoint asthe desired fluid pressure in the body cavity constituting the surgicalsite. In these embodiments, in addition to calculating the pressureadjustment based on the compensation height H3 described with referenceto FIG. 81A, the system 100 may also take into account knownrestrictions of the tubing set and assumed or calibrated restrictions ofthe surgical scope or instrument to determine the required systempressure. Accordingly, in some embodiments, the user may elect for thesystem 100 to monitor and display (via the graphical user interface 110)the fluid pressure at the system, fluid pressure at the surgical scopeor instrument, or fluid pressure in the body cavity constituting thesurgical site.

In endoscopic surgical procedures, good, steady distention and clearvisibility are important to procedural efficacy and efficiency. Althoughfluid pressure and flow rate are the primary factors to achievesatisfactory surgical site distention and visibility, some users maylack a clear understanding of how fluid pressure and/or flow rate (asimpacted by surgical site conditions and fluid inflow and outflowrestrictions of the surgical instrument and the tubing sets deliveringfluid to and from the surgical site) affect distention and visibility.Referring to FIG. 83, in an exemplary embodiment, the system 100 mayalternatively be set to a flex control mode that allows a user toachieve desired surgical site conditions simply by making distention andvisualization adjustments. That is, in this mode, the user is notconcerned with whether the system 100 is operating fluid pressurecontrol mode or the fluid flow rate control mode, nor is the userconcerned with the setpoint pressure or flow rate. Instead, the user mayprovide feedback to the system 100 regarding the surgical siteconditions via the user interface 110, and the system 100 determineswhether to operate in pressure or flow control mode, as well asdetermines the proper setpoint for fluid pressure and/or flow rate forthe procedure.

Referring to FIG. 83, if the user selects the flex control mode, thesystem 100 sets a default fluid pressure setpoint for the procedure andpresents “Distention” controls or buttons 8351, 8352 and “Visualization”controls or buttons 8353, 8354 on the user interface 110. For example,the user may increase distention by pressing the “+” (increase) button8351 or may decrease distention by pressing the “−” (decrease) button8352, and the user may increase visualization by pressing the “+”(increase) button 8353 or may decrease visualization by pressing the “−”(decrease) button 8354. The user interface 110 may also display otherinformation (similar to the procedure run screen 8101 shown in FIG. 81).For example, the user interface 110 may display fluid inflow or volumepumped 8321 to the surgical site, the fluid flow rate 8323, and/or thefluid pressure 8324. The user interface may also display the fluidtemperature 8312 and allow a user to enable/disable the fluid warmingfunction by using switch 8313. The user interface 110 may also have anavigation bar consisting of icons or buttons that can be used before orduring the procedure, such as, for examples, a “Settings” button 8328, a“Help” or “Troubleshooting” button 8327, a “Notifications” button 8329,a “Maintenance” button 8331, and/or an “End Case” or “End Procedure”button 8333.

Referring to FIG. 84, when the system is set to flex control mode (asshown at 8402), the system 100 may default to pressure control mode (asshown at 8404). In the illustrated embodiment, the adjustment ofdistention puts the system in fluid pressure control mode and adjuststhe pressure setpoint for the procedure, and the adjustment ofvisualization puts the system in fluid flow rate control mode andadjusts the flow rate set point for the procedure.

If a user adjusts the distention (as shown at 8406), the system 100maintains or transitions to the pressure control mode setting (as shownat 8408) such that the system 100 can adjust the setpoint pressure ofthe procedure to meet the desired distention by the user. In variousembodiments, distention adjustment to the fluid pressure setpoint cannever exceed the maximum allowable setpoint pressure for the procedure.If the user indicates that additional distention is desirable, but thepressure setpoint is at the maximum allowable level (as shown at 8410),the system 100 determines whether the flow rate for the system 100 is atthe maximum allowable flow rate (as shown at 8412). If the flow rate isat the maximum allowable flow rate, the system 100 can notify the user(via the user interface 110) that the system 100 is operating at itspressure and flow rate limits for the procedure (as shown at 8414). Ifthe flow rate is not at the maximum allowable flow rate, the system 100can instruct the user to open the scope inflow and outflow valves toincrease the fluid flow rate (as shown at 8416) and thereby increase thefluid moving through the surgical site. Going back to the step shown at8410, if the setpoint pressure of the fluid is not at the maximumallowable pressure, the system 100 determines whether the flow rate forthe system 100 is at the maximum allowable flow rate (as shown at 8418).If the flow rate is at the maximum allowable flow rate, the system 100can instruct the user to restrict fluid outflow from the surgical site(as shown at 8420) by partially closing the scope outflow valve,partially closing a clamp on the outflow tubing, and/or using a fixed orvariable restrictor component in the outflow tubing of the surgicalinstrument. If the flow rate is not at the maximum allowable flow rate,the system 100 can increase the pressure setpoint (as shown at 8422) toincrease the distention.

If a user adjusts the visualization (as shown at 8424), the system 100maintains or transitions to the flow control mode setting (as shown at8426) such that the system 100 can adjust the setpoint flow rate of theprocedure to meet the desired visualization by the user. In variousembodiments, visualization adjustment to the fluid flow rate setpointcan never exceed the maximum allowable setpoint flow rate for theprocedure. If the flow rate setpoint is at the maximum allowable level(as shown at 8428), the system 100 determines whether the fluid pressurefor the system 100 is at the maximum allowable pressure (as shown at8430). If the pressure is at the maximum allowable pressure, the system100 can notify the user (via the user interface 110) that the system 100is operating at its pressure and flow rate limits for the procedure (asshown at 8414). If the pressure is not at the maximum allowable flowrate, the system 100 can instruct the user to restrict fluid outflowfrom the surgical site (as shown at 8432), which allows the system 100to increase the pressure of the fluid in the surgical site. The user canrestrict outflow from the surgical site by, for example, partiallyclosing an outflow valve of the surgical instrument, partially closing aclamp on the outflow tubing, and/or using a fixed or variable restrictorcomponent in the outflow tubing of the surgical instrument. Going backto the step shown at 8428, if the setpoint flow rate of the fluid is notat the maximum allowable flow rate, the system 100 determines whetherthe fluid pressure for the system 100 is at the maximum allowable flowrate (as shown at 8434). If the pressure is at the maximum allowablepressure, the system 100 can instruct the user to open scope inflow andoutflow valves (as shown at 8436) to increase the fluid flow ratethrough the surgical site. If the pressure is not at the maximumallowable pressure, the system 100 can increase the flow rate setpoint(as shown at 8438) to increase the visualization.

In other words, by utilizing the distention controls 8351, 8352, theuser puts the system 100 in pressure control mode and adjusts thesetpoint fluid pressure for the procedure up to the maximum allowablelevel for the procedure, while maintaining a maximum allowable flow ratewhich cannot be exceeded. By utilizing the visualization controls 8353,8354, the user puts the system 100 in flow control mode and adjusts thesetpoint fluid flow rate for the procedure up to the maximum allowablelevel for the procedure while maintaining a maximum allowable fluidpressure which cannot be exceeded. Accordingly, the system 100 providesthe user more intuitive control over the surgical site conditions whileat all times remaining within the safe pressure and flow rates for theprocedure and displaying the actual fluid pressure and flow rate.

Referring to FIGS. 85 through 87, the system 100 may include a bolusfeature or device that is used to temporarily increase the fluidpressure and/or flow rate to maintain or increase distention and/or tomaintain or increase fluid flow for procedural and/or visualizationpurposes. The bolus feature or device may include a “Bolus” icon orbutton on one of the screens comprising the graphical user interface;pneumatic, electric, or wireless foot pedal; and/or other actuatingdevice that allows a surgeon to temporarily increase the fluid pressureand/or flow rate for procedural and visualization purposes. The bolusdevice may be operatively connected to the pump 212 (FIG. 2) of thesystem 100 such that a surgeon can activate the bolus device totemporarily increase the pressure or flow rate by operation of the pump212, and such that the pump returns to the normal setting for providingfluid at the setpoint pressure and flow rate after the surgeondeactivates the bolus device. Because the surgeon operates the bolusdevice, the bolus device can be provided when needed without requiringmanual operation of a bolus device or the interaction of a circulatingnurse with the system. The bolus feature also prevents the setpointpressure and/or flow rate of the fluid management system to be changedfor only a temporary increase in the pressure and/or flow rate.

The bolus device may interface with the system pneumatically,electrically, or wirelessly (e.g., via Bluetooth). The bolus device canbe configured by the user via the user interface 110. For example, theuser (via the user interface 110) may use a toggle switch 8510 to changethe bolus device between an “On” and “Off” state. In certainembodiments, the user may elect to have the bolus device operate in amomentary mode 8501 where the increase is sustained for as long as thefoot pedal is pressed. The user may alternatively elect to have thebolus device operate in a maintained mode 8503 where the foot pedal ispressed to activate the bolus device and pressed again to deactivate thebolus device. In another embodiment, the user may elect to have thebolus device operated in a timed mode (not shown) where the foot pedalis pressed to activate the bolus device, and the system 100 maintainsthe bolus device in the activate state for a desired amount of time.Whether the increase caused by the bolus device is to the fluid pressureor flow rate setpoint may depend, for example, on whether the system 100is in pressure mode or flow control mode at the time of bolusactivation. The user may elect to have the increase equal a setincrement (e.g., a 25 mmHg pressure increase or a 50 ml/min flow rateincrease), a percentage increase over setpoint (e.g., 20%), or themaximum allowable fluid pressure or fluid flow rate for the procedure.The increase in fluid pressure and fluid flow rate may be limited to themaximum allowable setpoint for the procedure.

The bolus device of the present application is beneficial because thefluid pressure or flow rate increase is known and safe. That is, theuser sets the increase, the actual fluid pressure and flow rate aredisplayed on the user interface 110 of the system 100, and the increasenever exceeds the max allowable safe limit for the procedure. Inaddition, the duration of the increase is appropriate as determined andcontrolled by the surgeon. Also, because the surgeon controls the bolusdevice via, for example, a foot pedal, the bolus device does not need tobe operated by a circulating nurse, and the bolus device does notinvolve interacting with the system.

In an alternative embodiment, the system 100 may include a temporaryadjustment feature or device that is used to temporarily increase ordecrease the fluid pressure and/or flow rate, which allows a user totemporarily increase or decrease distention and/or visualization at thesurgical site. This adjustment feature or device may include a“Temporary” icon or button representing a temporary adjustment on one ofthe screens comprising the graphical user interface in combination witha foot pedal or other type of actuating device. In certain embodiments,the actuating device includes a pneumatic, electric, or wireless footpedal(s) such as a foot pedal with rocker action or a dual foot pedalarrangement that allows a surgeon to temporarily increase or decreasethe fluid pressure and/or flow rate for procedural and visualizationpurposes. The adjustment device may be operatively connected to the pump212 (FIG. 2) of the system 100 such that a surgeon can activate thedevice to temporarily increase or decrease the pressure or flow rate byoperation of the pump 212, and such that the pump returns to the normalsetting for providing fluid at the setpoint pressure and flow rate afterthe surgeon deactivates the adjustment device. Because the surgeonoperates the adjustment device, the temporary adjustment to pressureand/or flow rate can be provided when needed without requiring manualoperation of a device or the interaction of a circulating nurse with thesystem 100. The adjustment device may interface with the systempneumatically, electrically, or wirelessly (e.g., via Bluetooth) and canbe configured by the user via the user interface 110 for mode (momentaryor maintained) and adjustment type (fixed, percentage, or max).

In certain embodiments, the system 100 may include a printer (e.g.,printer 218 shown in FIG. 2) for printing out pertinent informationregarding a surgical procedure during or after the procedure. Referringto FIG. 88, in situations in which the system 100 is tracking a fluiddeficit for the procedure, the user may elect (via the user interface110) to have the fluid deficit automatically recorded and printed out atset time intervals during the procedure (e.g., every 10 minutes). Asillustrated in FIG. 88, the user interface 110 may include a togglebutton to turn on or off the automatic recording and printing of fluiddeficit at set time intervals during the procedure. This capabilityeliminates the need for the user to periodically check and manuallyrecord or print out the fluid deficit information. In some embodiments,the user may (via the user interface 110) request to have the fluiddeficit recorded at set time intervals during the procedure and printedat the end of the procedure. In some embodiments, the user may (via theuser interface 110) request that the deficit information from previoustime intervals be displayed. In some embodiments, the system 100 may beconfigured to print the fluid deficit at volume intervals of the deficitmonitoring (e.g., every 50 ml of volume for each fluid deficitindividually and/or the total fluid deficit). In some embodiments,rather than printing to a printer of the system 100 itself, the system100 may be configured to automatically communicate with a printer of thefacility in which the system 100 is being used (e.g., via wire,Bluetooth, or WiFi) and print pertinent information at during or afterthe procedure, or at set time intervals during the procedure.

The system 100 can be configured to offer the user the ability toprintout pertinent procedure information at the end of the procedure,including, but not limited to, the date, procedure type, start time, endtime, fluid volume pumped, fluid deficit (if applicable), fluid deficitat set time intervals (if applicable), average fluid pressure, fluidwarming enabled/disabled, and/or average fluid temperature. In someembodiments, the user may be able to elect to have different oradditional information printed, including, but not limited to, facilityinformation, physician information, patient information, fluid deficitby fluid type (if applicable), fluid deficit by time increment (ifapplicable), fluid pressure range, fluid flow range, notifications andalerts list, and alarms list. Additionally, the user may elect totransmit pertinent procedure information via the Bluetooth or Wi-Ficapabilities of the system 100 to a data collection and/or recordretention system of the facility.

To avoid procedure interruption caused by depleted fluid supply bags,the system 100 may record the initial weight of the fluid supply baghung on each hanging member 116 (FIG. 1), the current weight of thefluid supply bag on each hanging member 116, and the current fluid flowrate for the procedure. The system 100 may also be able to provideaudible and/or visual indicators if the system 100 determines that afluid bag may become depleted. The system 100 may also provide anaudible and visible indication when the estimated time before a fluidbag will become depleted has fallen below a specified level.

Alternatively, referring to FIGS. 89 through 91, the user may elect toreceive audible and/or visual indicators (via the user interface 110) ifthe percentage of fluid remaining (based on the initial volume of thefluid bag) falls below a specified level. Referring to FIG. 89, thesystem 100 can be set to a “Time” setting 8902 that notifies a user whenthe amount of time until a bag becomes depleted drops below apredetermined amount of time (as shown at 8903) based on the current oraverage fluid flow rate. The system 100 may, alternatively, be set to a“Percentage” setting 8904 that notifies a user when a percentage of thefluid supply remaining drops below a predetermine percentage (as shownat 8904). Alternatively, the system 100 may be set to a “Volume” setting8906 that notifies a user when a volume of fluid remaining in the fluidsupply container drops below a predetermined volume (as shown at 8907).Provided the above-mentioned levels are set appropriately, the user(typically a circulating nurse) has time to replace a fluid bag withoutan interruption to the procedure. To avoid confusion and ensure elevatedlevels of attention for alarm conditions, the user may mute or reducethe sound level of certain indicators, alerts, and alarms provided byswitch or button 8910 and selection window 8912. In some embodiments,however, adjustment of the alerts/indicators is not possible for certainsafety critical alarms.

Referring to FIGS. 92 and 93, an exemplary embodiment of a fluidmanagement system 9200 for a physician's office environment wheregynecological and urological procedures are performed is shown. Thesystem 9200 includes a main unit 9202 that may include any or all of thefeatures described above for the main unit 102 of the fluid managementsystem 100 used in an operating room environment. For example, the mainunit 9202 may include a control system that has one or more processors(not shown) for controlling various components of the system 9200 (e.g.,a user interface, and various fluid pressure sensors, vacuum pressuresensors, fluid temperature sensors, fluid presence sensors, etc.). Theprocessors may execute instructions (e.g., software code) stored in amemory (not shown) of the system 100 and/or execute instructionsinputted into the system by a user. In some embodiments, the controlsystem may have “Bluetooth” capability for connecting to remotelylocated components or modules of the system 9200 and “Wi-Fi” capabilityfor connecting to the internet. The control system may include atouch-screen graphical user interface 9210 for receiving one or moreinputs from a user and displaying information of the system 9202 (e.g.,information regarding fluid deficit, fluid temperature, fluid pressure,distention, visualization, etc.).

The main unit 9202 may also include a pump (e.g., pump 212 shown in FIG.2) for fluid pressurization, a vacuum pump for providing suction, afluid conditioning assembly (e.g., fluid conditioning assembly 315 shownin FIG. 3) for receiving a fluid conditioner (e.g., fluid conditioner420 shown in FIG. 10) and sensing one or more characteristics (e.g.,fluid presence, fluid temperature, etc.) of fluid moving through thefluid conditioner, hanging members 9216 (e.g., hooks) for hanging fluidsupply or collection containers 9217 (e.g., bags, canisters, vessels,etc.). In some embodiments, the main unit 9202 may include a heatingassembly (e.g., heating assembly 314 shown in FIG. 3) for receiving awarming cartridge (e.g., warming cartridge 422 shown in FIGS. 14-18)such that system can be configured for fluid warming during theprocedure, if applicable. The processor of the control system can be incircuit communication with the pump, sensors, fluid conditioningassembly, heating assembly (if applicable), and hanging members 9216;and the processor can be configured to control these components. Incertain embodiments, the hanging members 9216 are operatively connectedto load cells such that the control system can monitor a weight of thefluid containers 9217.

Although the system 100 for the operating room environment may include acartridge assembly 419 (FIG. 4) that includes a fluid conditioner 420and a fluid warming cartridge 422, the system 9200 for the physician'soffice may or may not include a fluid warming function. In embodimentsthat do not include a fluid warming function, the fluid conditioner 420described with reference to the system 100 may also be used with thesystem 9200, but the fluid conditioner 420 may include a connector ortube 841 (FIG. 8), a pulse damping component, or a channel integral tothe fluid conditioner 420 that connects the inlet chamber 1053 (FIG. 10)to the outlet chamber 1054 (FIG. 10), rather than the warming cartridge422. If the system 9200 does include a fluid warming component, awarming cartridge (e.g., warming cartridge 422 shown in FIGS. 14-18) canbe an accessory that attaches to the fluid conditioner 420 such that thesystem 9200 can perform fluid warming.

The system 9200 may be configured to perform deficit monitoring by aweight-based method, as compared to the flow-based deficit monitoringmethod described with the fluid management system 100. Flow-baseddeficit monitoring (as used with the system 100) is appropriate for theoperating room environment due to the generally higher fluid volumeusage associated with the longer, more complex surgical proceduresperformed there. However, the complexity and cost of the flow-baseddeficit monitoring feature may not be necessary in a physician's officeenvironment, as the surgical procedures performed there are generallyshorter and use less fluid. Accordingly, the system 9200 may beconfigured to include weight-based deficit monitoring. In certainembodiments, the hanging members 9216 are configured for the dualpurpose of holding and monitoring the weight of the fluid containers9217. That is, the processor of the system 9200 can be operativelyconnected to the load cells of the hanging members 9216, which allowsthe system 9200 to monitor the weight of the fluid containers 9217. Atleast one fluid container 9217 is for supplying fluid to the surgicalsite, and at least one fluid container 9217 is for fluid returning fromthe surgical site. The system 9200 monitors the weight of the hangingmembers 9216 to determine the fluid inflow volume to the surgical site(by based on the weight of the fluid supply container) and the fluidoutflow volume returned from the surgical site (based on the weight ofthe fluid return container) to calculate the fluid deficit, which is thedifference between the fluid inflow volume and the fluid outflow volume.The system 9200 can be configured to monitor and display the fluidvolume and fluid deficit. The system 9200 can also be configured toprovide a notification or alarm if the deficit level exceeds the defaultlimit or the adjusted limit set by the user.

Similar to the system 100 described in the present application, thesystem 9200 may be configured to guide the user through the setupprocess using instructions, illustrations, animations, and/or systemfeedback via the user interface 9210. For example, the system 9200 mayfirst prompt the user to select the surgical discipline and procedurethat will be performed, which can cause the system 9200 to set thedefault operating parameters for the procedure as well as the safe,permissible adjustment ranges for those parameters.

If deficit monitoring is required or elected by the user, the system9200 can prompt the user to indicate the type of fluid that will beutilized and will set the maximum deficit limit for that fluid. Thesystem 9200 can then instruct the user to hang a fluid supply containerand indicate when the container has been placed on the hanging member9216 (with the system confirming placement by monitoring the weight ofeach hanging member). The system 9200 can also instruct the user to hangthe fluid supply container 9217 on a specific hanging member 9216 (withthe system 9200 confirming placement by monitoring the weight of thedesignated hanging member). The system 9200 may then instruct the userto connect the fluid return lines to a fluid return container 9217,connect the fluid return container 9217 to a suction source (e.g., anintegrated suction source of the main unit 9200 or an external suctionsource), and then to hang the fluid return container on another hangingmember 9216. When the system 9200 senses that the fluid return container9217 has been hung, it may set and record the empty fluid containerweight to zero such that the system 9200 can properly calculate thefluid deficit for the procedure. Alternatively, the system 9200 caninstruct the user place fluid supply container 9217 on the hangingmember 9216, and when the system 9200 senses that a fluid supplycontainer is properly placed, the system 9200 can instruct the user toprepare and hang a fluid return container as discussed above. The system9200 can properly assign hanging members for each of the fluid supplycontainers and fluid return containers by monitoring the weight changesof the respective hanging members during the process, or by comparingthe respective weight on the hanging members after the process has beencompleted. Although the system 9200 can accommodate standard canistersthat can hold up to 5 L of fluid, the packaging of the tubing setsintended for procedures performed in the physician office environmentcan also be used for the described fluid collection function.

If deficit monitoring is not required or elected, the system 9200 canprompt the user to place the fluid supply containers 9217 on the hangingmembers 9216, place or route the tubing connecting the fluidcontainers(s) with the fluid conditioner (e.g., fluid conditioner 420),into or through the pump 212, and insert the fluid conditioner into themain unit 9202.

Following the tubing installation process, the system 9200 can theninstruct the user to complete the priming process as described abovewith reference to the system 100. When priming is complete, the userinterface can transition to a procedure run screen (e.g., procedure runscreen 8101) where the user may start and control the procedure.

While various inventive aspects, concepts and features of thedisclosures may be described and illustrated herein as embodied incombination in the exemplary embodiments, these various aspects,concepts, and features may be used in many alternative embodiments,either individually or in various combinations and sub-combinationsthereof. Unless expressly excluded herein all such combinations andsub-combinations are intended to be within the scope of the presentapplication. Still further, while various alternative embodiments as tothe various aspects, concepts, and features of the disclosures—such asalternative materials, structures, configurations, methods, devices, andcomponents, alternatives as to form, fit, and function, and so on—may bedescribed herein, such descriptions are not intended to be a complete orexhaustive list of available alternative embodiments, whether presentlyknown or later developed. Those skilled in the art may readily adopt oneor more of the inventive aspects, concepts, or features into additionalembodiments and uses within the scope of the present application even ifsuch embodiments are not expressly disclosed herein.

Additionally, even though some features, concepts, or aspects of thedisclosures may be described herein as being a preferred arrangement ormethod, such description is not intended to suggest that such feature isrequired or necessary unless expressly so stated. Still further,exemplary or representative values and ranges may be included to assistin understanding the present application, however, such values andranges are not to be construed in a limiting sense and are intended tobe critical values or ranges only if so expressly stated.

Moreover, while various aspects, features and concepts may be expresslyidentified herein as being inventive or forming part of a disclosure,such identification is not intended to be exclusive, but rather theremay be inventive aspects, concepts, and features that are fullydescribed herein without being expressly identified as such or as partof a specific disclosure, the disclosures instead being set forth in theappended claims. Descriptions of exemplary methods or processes are notlimited to inclusion of all steps as being required in all cases, nor isthe order that the steps are presented to be construed as required ornecessary unless expressly so stated. The words used in the claims havetheir full ordinary meanings and are not limited in any way by thedescription of the embodiments in the specification.

1. A pressure regulator, comprising: a first chamber having an inletopening for fluidly connecting to an external pressure source; a secondchamber having an outlet opening for supplying a regulated pressure to aregulated source; a third chamber having a pressure opening forconnection to a pressure source; and a flexible membrane fluidlyisolating the third chamber from both of the first and second chambers,wherein the flexible membrane is movable by the pressure source betweena first position in which the flexible membrane fluidly isolates thefirst chamber from the second chamber and a second position in which thefirst and second chambers are fluidly connected.
 2. The pressureregulator according to claim 1, wherein the flexible membrane defines aportion of each of the first, second, and third chambers.
 3. Thepressure regulator according to claim 1, wherein the third chamberfurther comprises a sensing opening for connecting to a pressure sensorthat is configured to sense a pressure supplied by the pressure source.4. The pressure regulator according to claim 1, further comprising ahousing that defines the first, second, and third chambers.
 5. Thepressure regulator according to claim 4, wherein the housing comprises afirst component that forms the first and second chambers and a secondcomponent that forms the third chamber.
 6. The pressure regulatoraccording to claim 4, wherein the housing is made of polycarbonate 7.The pressure regulator according to claim 1, wherein the flexiblemembrane is made of at least one of neoprene, silicone, natural rubber,nitrile, or EPDM.
 8. The pressure regulator according to claim 1,wherein the flexible membrane is configured to move to the secondposition and allow the regulated pressure supplied through the outletopening of the second chamber to be between about 10 mmHg and about 30mmHg greater than a pressure provided by the pressure source through thepressure opening and into the third chamber.
 9. The pressure regulatoraccording to claim 1, wherein a wall is positioned between the first andsecond chambers, and wherein the flexible membrane engages the wall whenin the first position and disengages the wall when in the secondposition.
 10. A pressure regulator, comprising: a first chamber havingan inlet opening for connecting to an external pressure source; a secondchamber having an outlet opening for supplying a regulated pressure to aregulated source; a third chamber having a pressure opening forconnecting to a pressure source; a fourth chamber having a sensingopening for connecting to a pressure sensor that senses a pressure inthe fourth chamber; a flexible membrane fluidly isolating the third andfourth chambers from both of the first and second chambers, wherein theflexible membrane is movable by a vacuum pressure applied to the firstchamber such that the third and fourth chambers are fluidly connected,and wherein the flexible membrane is movable by a pressure applied bythe pressure source such that the first and second chambers are fluidlyconnected.
 11. The pressure regulator according to claim 10, wherein theflexible membrane defines a portion of each of the first, second, third,and fourth chambers.
 12. The pressure regulator according to claim 10,wherein the fourth chamber further comprises an air bleed mechanism forbleeding off pressure in the fourth chamber.
 13. The pressure regulatoraccording to claim 12, wherein the air bleed mechanism comprises a smallorifice.
 14. The pressure regulator according to claim 12, wherein theair bleed mechanism comprises a valve.
 15. The pressure regulatoraccording to claim 10, further comprising a housing that defines thefirst, second, third, and fourth chambers.
 16. The pressure regulatoraccording to claim 15, wherein the housing comprises a first componentthat forms the first and second chambers and a second component thatforms the third and fourth chambers.
 17. The pressure regulatoraccording to claim 15, wherein the housing is made of polycarbonate. 18.The pressure regulator according to claim 10, wherein the flexiblemembrane is made of at least one of neoprene, silicone, natural rubber,nitrile, or EPDM.
 19. The pressure regulator according to claim 10,wherein the flexible membrane is configured to move and fluidly connectthe first and second chambers and allow the regulated pressure suppliedthrough the outlet opening of the second chamber to be between about 10mmHg and about 30 mmHg greater than a pressure provided by the pressuresource through the pressure opening and into the third chamber.
 20. Thepressure regulator according to claim 10, wherein a first wall ispositioned between the first and second chambers and a second wall ispositioned between the third and fourth chambers, wherein the flexiblemembrane is moved to disengage the second wall to fluidly connect thethird and fourth chambers, and wherein the flexible membrane is moved todisengage the first wall to fluidly connect the first and secondchambers.